Susan London

Major Finding: The rate of early IUD expulsion was 3.5% overall, with no significant difference among women who used pads (4%), tampons (2%), and menstrual cups (6%).

Data Source: A retrospective cohort study of 999 women undergoing IUD insertion.

Disclosures: Dr. Wiebe reported that she had no relevant conflicts of interest.

VANCOUVER, B.C. – Use of tampons or menstrual cups does not increase the risk of early expulsion of an intrauterine device, according to findings of a retrospective cohort study of nearly 1,000 women.

In the study, the overall rate of IUD expulsion within 2 months of insertion was low (3.5%), and was statistically no higher for women who used tampons or cups than it was for their counterparts who used pads.

“Women can be reassured that they can use whatever their usual menstrual product is and not increase their risk of expelling the IUD,” said coinvestigator Dr. Ellen Wiebe of the department of family practice at the University of British Columbia, Vancouver.

She noted that it is a common concern that vaginal menstrual products will tug on the IUD strings protruding from the cervix, thereby pulling the device out. And most IUD expulsions in the first year occur within a month of insertion (Hum. Reprod. Update 2008;14:197-208).

“Every day, I would get asked the question, 'Is it okay to use tampons with the IUD?' And every week or so, I would get asked the question, 'Is it okay to use a cup with the IUD?'” she related in an interview at the meeting “And I looked in the literature, and there were no answers.”

Moreover, IUD package inserts are inconsistent on the issue. For example, of the four IUDs on the market in Canada, the Mirena package insert says that tampons can be used, the Liberté insert notes that tampons can be used (but is silent on the use of menstrual cups), and the Flexi-T and Nova-T inserts do not mention menstrual products at all, she said.

She further noted that little is known about the prevalence of menstrual cup use today, as most studies on this product were done in the 1960s and focused on acceptability.

Dr. Wiebe and her colleague retrospectively reviewed the charts of 999 women who underwent IUD insertion at two reproductive health clinics in 2009.

Study results, reported in a poster session at the meeting, showed that about half the women had the hormonal Mirena IUD inserted and about half had one of the copper IUDs inserted. Among the 930 women having data on the type of menstrual product used, 74% used tampons, 43% used pads, and 10% used menstrual cups, with many using more than one product. Cup users were more likely than pad users and tampon users to be younger than 30 years of age (77% vs. 51% and 61%, respectively) and nulliparous (88% vs. 54% and 69%, respectively). Among the 620 women who had adequate follow-up, the rate of early IUD expulsion (defined as within 2 months of insertion) was 3.5% overall, and was statistically indistinguishable among women who used pads (4%), tampons (2%), and menstrual cups (6%).

Based on anecdotal evidence, “I knew it was fine, and most of our colleagues thought it was fine” to use tampons and menstrual cups with an IUD, said Dr. Wiebe.

“But that's not the evidence you want to give your patient,” she added. “You'd rather say, 'Well, we looked at 1,000 women and it didn't make any difference what they used.'

'Every day, I would get asked the question, “Is it okay to use tampons with the IUD?”'

Source DR. WIEBE

Major Finding: The rate of early IUD expulsion was 3.5% overall, with no significant difference among women who used pads (4%), tampons (2%), and menstrual cups (6%).

Data Source: A retrospective cohort study of 999 women undergoing IUD insertion.

Disclosures: Dr. Wiebe reported that she had no relevant conflicts of interest.

VANCOUVER, B.C. – Use of tampons or menstrual cups does not increase the risk of early expulsion of an intrauterine device, according to findings of a retrospective cohort study of nearly 1,000 women.

In the study, the overall rate of IUD expulsion within 2 months of insertion was low (3.5%), and was statistically no higher for women who used tampons or cups than it was for their counterparts who used pads.

“Women can be reassured that they can use whatever their usual menstrual product is and not increase their risk of expelling the IUD,” said coinvestigator Dr. Ellen Wiebe of the department of family practice at the University of British Columbia, Vancouver.

She noted that it is a common concern that vaginal menstrual products will tug on the IUD strings protruding from the cervix, thereby pulling the device out. And most IUD expulsions in the first year occur within a month of insertion (Hum. Reprod. Update 2008;14:197-208).

“Every day, I would get asked the question, 'Is it okay to use tampons with the IUD?' And every week or so, I would get asked the question, 'Is it okay to use a cup with the IUD?'” she related in an interview at the meeting “And I looked in the literature, and there were no answers.”

Moreover, IUD package inserts are inconsistent on the issue. For example, of the four IUDs on the market in Canada, the Mirena package insert says that tampons can be used, the Liberté insert notes that tampons can be used (but is silent on the use of menstrual cups), and the Flexi-T and Nova-T inserts do not mention menstrual products at all, she said.

She further noted that little is known about the prevalence of menstrual cup use today, as most studies on this product were done in the 1960s and focused on acceptability.

Dr. Wiebe and her colleague retrospectively reviewed the charts of 999 women who underwent IUD insertion at two reproductive health clinics in 2009.

Study results, reported in a poster session at the meeting, showed that about half the women had the hormonal Mirena IUD inserted and about half had one of the copper IUDs inserted. Among the 930 women having data on the type of menstrual product used, 74% used tampons, 43% used pads, and 10% used menstrual cups, with many using more than one product. Cup users were more likely than pad users and tampon users to be younger than 30 years of age (77% vs. 51% and 61%, respectively) and nulliparous (88% vs. 54% and 69%, respectively). Among the 620 women who had adequate follow-up, the rate of early IUD expulsion (defined as within 2 months of insertion) was 3.5% overall, and was statistically indistinguishable among women who used pads (4%), tampons (2%), and menstrual cups (6%).

Based on anecdotal evidence, “I knew it was fine, and most of our colleagues thought it was fine” to use tampons and menstrual cups with an IUD, said Dr. Wiebe.

“But that's not the evidence you want to give your patient,” she added. “You'd rather say, 'Well, we looked at 1,000 women and it didn't make any difference what they used.'

'Every day, I would get asked the question, “Is it okay to use tampons with the IUD?”'

Source DR. WIEBE

Major Finding: The rate of early IUD expulsion was 3.5% overall, with no significant difference among women who used pads (4%), tampons (2%), and menstrual cups (6%).

Data Source: A retrospective cohort study of 999 women undergoing IUD insertion.

Disclosures: Dr. Wiebe reported that she had no relevant conflicts of interest.

VANCOUVER, B.C. – Use of tampons or menstrual cups does not increase the risk of early expulsion of an intrauterine device, according to findings of a retrospective cohort study of nearly 1,000 women.

In the study, the overall rate of IUD expulsion within 2 months of insertion was low (3.5%), and was statistically no higher for women who used tampons or cups than it was for their counterparts who used pads.

“Women can be reassured that they can use whatever their usual menstrual product is and not increase their risk of expelling the IUD,” said coinvestigator Dr. Ellen Wiebe of the department of family practice at the University of British Columbia, Vancouver.

She noted that it is a common concern that vaginal menstrual products will tug on the IUD strings protruding from the cervix, thereby pulling the device out. And most IUD expulsions in the first year occur within a month of insertion (Hum. Reprod. Update 2008;14:197-208).

“Every day, I would get asked the question, 'Is it okay to use tampons with the IUD?' And every week or so, I would get asked the question, 'Is it okay to use a cup with the IUD?'” she related in an interview at the meeting “And I looked in the literature, and there were no answers.”

Moreover, IUD package inserts are inconsistent on the issue. For example, of the four IUDs on the market in Canada, the Mirena package insert says that tampons can be used, the Liberté insert notes that tampons can be used (but is silent on the use of menstrual cups), and the Flexi-T and Nova-T inserts do not mention menstrual products at all, she said.

She further noted that little is known about the prevalence of menstrual cup use today, as most studies on this product were done in the 1960s and focused on acceptability.

Dr. Wiebe and her colleague retrospectively reviewed the charts of 999 women who underwent IUD insertion at two reproductive health clinics in 2009.

Study results, reported in a poster session at the meeting, showed that about half the women had the hormonal Mirena IUD inserted and about half had one of the copper IUDs inserted. Among the 930 women having data on the type of menstrual product used, 74% used tampons, 43% used pads, and 10% used menstrual cups, with many using more than one product. Cup users were more likely than pad users and tampon users to be younger than 30 years of age (77% vs. 51% and 61%, respectively) and nulliparous (88% vs. 54% and 69%, respectively). Among the 620 women who had adequate follow-up, the rate of early IUD expulsion (defined as within 2 months of insertion) was 3.5% overall, and was statistically indistinguishable among women who used pads (4%), tampons (2%), and menstrual cups (6%).

Based on anecdotal evidence, “I knew it was fine, and most of our colleagues thought it was fine” to use tampons and menstrual cups with an IUD, said Dr. Wiebe.

“But that's not the evidence you want to give your patient,” she added. “You'd rather say, 'Well, we looked at 1,000 women and it didn't make any difference what they used.'

'Every day, I would get asked the question, “Is it okay to use tampons with the IUD?”'

Source DR. WIEBE

Major Finding: Overall, 22% of women became pregnant, and 18% of this group had a multiple pregnancy (usually a twin gestation).

Data Source: A retrospective analysis of 759 women with unexplained fertility who were treated with FSH, with or without intrauterine insemination.

Disclosures: Dr. Nourmoussavi reported that she had no relevant financial disclosures.

VANCOUVER, B.C. – Multiple pregnancy occurs in about one-fifth of women with unexplained infertility who become pregnant after treatment with follicle-stimulating hormone to induce superovulation, the largest study to look at this outcome found.

Investigators at the University of British Columbia, Vancouver, retrospectively studied 759 women whose infertility had no identifiable cause after a full work-up and who received FSH, with or without intrauterine insemination (IUI), a treatment that is a less costly and less invasive alternative to in vitro fertilization (IVF).

In all, 22% of the women became pregnant, according to results reported at the meeting Although 18% of the pregnant women had a multiple pregnancy, in most cases these were twin gestations. Multiple pregnancy was most common among women younger than 30 years of age.

“This study definitely provides information for patients when we are counseling them on the different treatment choices that are available, specifically for the group with unexplained infertility,” commented first author Dr. Melica Nourmoussavi, a resident in the department of ob.gyn. at the university. “And it's also very important for gynecologists who are concerned about the risks of multiple pregnancies when treating with FSH, with or without IUI.”

She acknowledged that such concerns are justified, and offered some guidance, based in part on the study's findings, for minimizing the likelihood of this outcome. “First of all, [make] appropriate patient selection; for example, [be] cautious when treating younger women because of their increased risk of multiple pregnancies,” she said. “Second, [consider] conversion to IVF or even cancellation of cycles when there are signs of overstimulation,” such as more than three mature follicles or multiple medium-size follicles. “And third, [use] minimal ovarian stimulation protocols for more controlled treatment.”

In the so-called stair-step approach to unexplained infertility (in which physicians work their way up from the least expensive, invasive, and stressful – but also least successful – treatments to those that are the most expensive, invasive, and stressful), FSH-induced superovulation, with or without IUI, comes after clomiphene, with or without IUI, but before IVF.

She and her colleagues retrospectively reviewed the charts of women with unexplained infertility who were treated with FSH, with or without IUI, at the university in 2002-2008.

The 759 women identified had a total of 1,387 cycles of treatment. Some 73% were aged 35 years or older.

Study results showed that the pregnancy rate was 22% in the study population as a whole, but it ranged from 12% among women aged 40 years or older to 31% among those aged 30-34 years.

In the group who became pregnant, the multiple pregnancy rate was 18%, with a range spanning from 9% among women aged 40 years or older to 33% among those younger than 30 years of age.

Most of these multiple pregnancies (87%) were twin gestations, whereas the rest were triplet gestations. In all, 16% of the multiple pregnancies were reduced to singleton pregnancies.

An analysis of the cumulative pregnancy rate with treatment showed that although the pregnancy rate did increase with each cycle regardless of a woman's age, the increase was much smaller in women older than 40 years.

Major Finding: Overall, 22% of women became pregnant, and 18% of this group had a multiple pregnancy (usually a twin gestation).

Data Source: A retrospective analysis of 759 women with unexplained fertility who were treated with FSH, with or without intrauterine insemination.

Disclosures: Dr. Nourmoussavi reported that she had no relevant financial disclosures.

VANCOUVER, B.C. – Multiple pregnancy occurs in about one-fifth of women with unexplained infertility who become pregnant after treatment with follicle-stimulating hormone to induce superovulation, the largest study to look at this outcome found.

Investigators at the University of British Columbia, Vancouver, retrospectively studied 759 women whose infertility had no identifiable cause after a full work-up and who received FSH, with or without intrauterine insemination (IUI), a treatment that is a less costly and less invasive alternative to in vitro fertilization (IVF).

In all, 22% of the women became pregnant, according to results reported at the meeting Although 18% of the pregnant women had a multiple pregnancy, in most cases these were twin gestations. Multiple pregnancy was most common among women younger than 30 years of age.

“This study definitely provides information for patients when we are counseling them on the different treatment choices that are available, specifically for the group with unexplained infertility,” commented first author Dr. Melica Nourmoussavi, a resident in the department of ob.gyn. at the university. “And it's also very important for gynecologists who are concerned about the risks of multiple pregnancies when treating with FSH, with or without IUI.”

She acknowledged that such concerns are justified, and offered some guidance, based in part on the study's findings, for minimizing the likelihood of this outcome. “First of all, [make] appropriate patient selection; for example, [be] cautious when treating younger women because of their increased risk of multiple pregnancies,” she said. “Second, [consider] conversion to IVF or even cancellation of cycles when there are signs of overstimulation,” such as more than three mature follicles or multiple medium-size follicles. “And third, [use] minimal ovarian stimulation protocols for more controlled treatment.”

In the so-called stair-step approach to unexplained infertility (in which physicians work their way up from the least expensive, invasive, and stressful – but also least successful – treatments to those that are the most expensive, invasive, and stressful), FSH-induced superovulation, with or without IUI, comes after clomiphene, with or without IUI, but before IVF.

She and her colleagues retrospectively reviewed the charts of women with unexplained infertility who were treated with FSH, with or without IUI, at the university in 2002-2008.

The 759 women identified had a total of 1,387 cycles of treatment. Some 73% were aged 35 years or older.

Study results showed that the pregnancy rate was 22% in the study population as a whole, but it ranged from 12% among women aged 40 years or older to 31% among those aged 30-34 years.

In the group who became pregnant, the multiple pregnancy rate was 18%, with a range spanning from 9% among women aged 40 years or older to 33% among those younger than 30 years of age.

Most of these multiple pregnancies (87%) were twin gestations, whereas the rest were triplet gestations. In all, 16% of the multiple pregnancies were reduced to singleton pregnancies.

An analysis of the cumulative pregnancy rate with treatment showed that although the pregnancy rate did increase with each cycle regardless of a woman's age, the increase was much smaller in women older than 40 years.

Major Finding: Overall, 22% of women became pregnant, and 18% of this group had a multiple pregnancy (usually a twin gestation).

Data Source: A retrospective analysis of 759 women with unexplained fertility who were treated with FSH, with or without intrauterine insemination.

Disclosures: Dr. Nourmoussavi reported that she had no relevant financial disclosures.

VANCOUVER, B.C. – Multiple pregnancy occurs in about one-fifth of women with unexplained infertility who become pregnant after treatment with follicle-stimulating hormone to induce superovulation, the largest study to look at this outcome found.

Investigators at the University of British Columbia, Vancouver, retrospectively studied 759 women whose infertility had no identifiable cause after a full work-up and who received FSH, with or without intrauterine insemination (IUI), a treatment that is a less costly and less invasive alternative to in vitro fertilization (IVF).

In all, 22% of the women became pregnant, according to results reported at the meeting Although 18% of the pregnant women had a multiple pregnancy, in most cases these were twin gestations. Multiple pregnancy was most common among women younger than 30 years of age.

“This study definitely provides information for patients when we are counseling them on the different treatment choices that are available, specifically for the group with unexplained infertility,” commented first author Dr. Melica Nourmoussavi, a resident in the department of ob.gyn. at the university. “And it's also very important for gynecologists who are concerned about the risks of multiple pregnancies when treating with FSH, with or without IUI.”

She acknowledged that such concerns are justified, and offered some guidance, based in part on the study's findings, for minimizing the likelihood of this outcome. “First of all, [make] appropriate patient selection; for example, [be] cautious when treating younger women because of their increased risk of multiple pregnancies,” she said. “Second, [consider] conversion to IVF or even cancellation of cycles when there are signs of overstimulation,” such as more than three mature follicles or multiple medium-size follicles. “And third, [use] minimal ovarian stimulation protocols for more controlled treatment.”

In the so-called stair-step approach to unexplained infertility (in which physicians work their way up from the least expensive, invasive, and stressful – but also least successful – treatments to those that are the most expensive, invasive, and stressful), FSH-induced superovulation, with or without IUI, comes after clomiphene, with or without IUI, but before IVF.

She and her colleagues retrospectively reviewed the charts of women with unexplained infertility who were treated with FSH, with or without IUI, at the university in 2002-2008.

The 759 women identified had a total of 1,387 cycles of treatment. Some 73% were aged 35 years or older.

Study results showed that the pregnancy rate was 22% in the study population as a whole, but it ranged from 12% among women aged 40 years or older to 31% among those aged 30-34 years.

In the group who became pregnant, the multiple pregnancy rate was 18%, with a range spanning from 9% among women aged 40 years or older to 33% among those younger than 30 years of age.

Most of these multiple pregnancies (87%) were twin gestations, whereas the rest were triplet gestations. In all, 16% of the multiple pregnancies were reduced to singleton pregnancies.

An analysis of the cumulative pregnancy rate with treatment showed that although the pregnancy rate did increase with each cycle regardless of a woman's age, the increase was much smaller in women older than 40 years.

VANCOUVER – A clinical trial is needed to assess the risk-benefit profile of salpingectomy for ovarian cancer prevention, said Dr. Barry Rosen.

A recent, serendipitous discovery, resulting from pathology examination of tissues removed during prophylactic salpingo-oophorectomy in patients with BRCA mutations, was that serous "ovarian" cancers actually arise from the fimbriae of the fallopian tubes.

"We didn’t know it when we started doing [the surgery]," Dr. Rosen explained at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. "We sort of all of a sudden started to identify cancers, and most of them were in the tube. ... All of a sudden, there has been a shift in the understanding that serous carcinomas do come from the tube."

In the wake of this new information, the Society of Gynecologic Oncology of Canada (GOC) issued two key recommendations, according to Dr. Rosen, professor of ob.gyn. and head of gynecologic oncology at the University of Toronto.

First, the GOC recommends that physicians discuss the risk-benefit profile of salpingectomy with women who are already having a hysterectomy or seeking irreversible contraception. "We don’t come out and say ‘Do it,’ " he noted. "But we are coming out to say that it makes sense, and you should discuss it, and in that discussion, if it makes sense, that you should go ahead and proceed to do it."

Second, the GOC recommends that, given the lack of evidence, a national study of ovarian cancer prevention through salpingectomy be a priority of the society. "We want to collect the evidence to support this, and we want to be sure that the evidence supports it before we really jump in and say everybody should be doing this," Dr. Rosen said.

"I don’t think there’s any question that salpingectomy makes sense. Serous carcinoma is the worst [ovarian] cancer, it’s the most common cancer, [and] it causes more deaths than any," he commented. "So if you can prevent this cancer, you are probably going to have the biggest impact on ovarian cancer that we have today. Bigger than screening, for sure – we know [screening] doesn’t work. But bigger than any treatment and any of the fancy treatments that are coming out that are really very expensive treatments."

Adding salpingectomy to other, planned surgeries could potentially provide preventive benefit to tens of thousands of women annually in Canada alone. For starters, roughly 47,000 Canadian women undergo hysterectomy nationally each year. Removal of the ovaries and tubes at the same time is fairly standard for those who are postmenopausal. "But it’s the premenopausal women for whom you would have the benefit of taking out the tubes and leaving the ovaries so that they could continue to have their hormone function," he noted.

And the procedure could be offered even more widely. For example, approximately 10,100 new cases of colon cancer are diagnosed annually among Canadian women, many of whom undergo pelvic surgery as a result.

There are many "other situations where urologists or general surgeons are doing surgery, so I don’t think we have to limit this discussion to gynecologists," commented Dr. Rosen. "We need to expand it to all disciplines that may operate in the pelvis, because a surgeon can take out the tubes as well as we can."

When asked by an attendee whether it might perhaps be better to recommend simpler distal salpingectomy instead of total salpingectomy, he expressed reservations.

"While the belief is that most of these cancers arise in the fimbriated end, there are some that do arise further up the tube." Additionally, "we have to be careful if we put in the word ‘distal.’ We also have to define what distal is. So it’s trickier than you think."

Dr. Rosen offered a few notes of caution from his own perspective. "Salpingectomy at open hysterectomy is different than at laparoscopic hysterectomy or tubal ligation," he said. "It’s pretty simple if you have an open case to be able to put your favorite clamp across the tube and remove it; laparascopically, [for some it may be] a little bit more difficult. ... When doing the procedure, you need to treat this as a surgical procedure, and not just think, ‘Oh yeah, we’ll just take out the tubes,’ and find yourself in some trouble with bleeding or an injury of some sort."

Also, the medical profession must decide what level of complications is acceptable. "I don’t know the answer to that, but we need to know what the complication rate is, and we do know that there will be complications," he said.

Finally, the new recommendations are currently based on a hypothesis, not on evidence. "There are other situations in our history in medicine where physicians really believed something very strongly and proceeded with limited information," he noted, citing by way of example the use of diethylstilbestrol in the 1940s and 1950s to prevent miscarriage, and its subsequent linkage to cancer. "We need to be sure that we get the evidence. I believe that we need to evaluate this in some form of clinical trial."

Should salpingectomy prove to be effective and adequately safe for preventing ovarian cancer, it would constitute a major turning point in a disease that still has a poor prognosis, according to Dr. Rosen.

To be sure, treatments have improved steadily over the past 25 years, prolonging life and improving its quality. "We can continue to expect improvements, but I think they are going to be gradual and they are going to be small," he said. "I don’t think anybody would say that there are any home runs out there right now."

Efforts to detect the cancer early through screening have thus far not panned out. Three large screening studies were initiated in 1985-2001, one each in the United Kingdom, Japan, and the United States.

Results from the last – the PLCO (Prostate, Lung, Colorectal, and Ovarian) trial, which tested screening with cancer antigen 125 (CA 125) and transvaginal ultrasound – were recently reported (JAMA 2011;305:2295-303). They showed that 20 surgeries had to be performed to detect one cancer, and the rate of major complications was 20% among patients who underwent surgery. And at the end of the day, there was no reduction in ovarian cancer mortality.

"This is a big study, it is very well done, [and] it has a very long follow-up," Dr. Rosen commented. "And I think this pretty much conclusively says that ultrasound and CA 125 [screening] just don’t work." Results of the U.K. study, which is using a different, serial multimodality approach to screening, are expected in the 2014 timeframe.

Prevention efforts up to this point have been limited to birth control pills and to BRCA testing with prophylactic surgery for carriers, but this group makes up only about a tenth of all patients with ovarian cancer, he noted.

Dr. Rosen said he had no relevant financial disclosures.

VANCOUVER – A clinical trial is needed to assess the risk-benefit profile of salpingectomy for ovarian cancer prevention, said Dr. Barry Rosen.

A recent, serendipitous discovery, resulting from pathology examination of tissues removed during prophylactic salpingo-oophorectomy in patients with BRCA mutations, was that serous "ovarian" cancers actually arise from the fimbriae of the fallopian tubes.

"We didn’t know it when we started doing [the surgery]," Dr. Rosen explained at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. "We sort of all of a sudden started to identify cancers, and most of them were in the tube. ... All of a sudden, there has been a shift in the understanding that serous carcinomas do come from the tube."

In the wake of this new information, the Society of Gynecologic Oncology of Canada (GOC) issued two key recommendations, according to Dr. Rosen, professor of ob.gyn. and head of gynecologic oncology at the University of Toronto.

First, the GOC recommends that physicians discuss the risk-benefit profile of salpingectomy with women who are already having a hysterectomy or seeking irreversible contraception. "We don’t come out and say ‘Do it,’ " he noted. "But we are coming out to say that it makes sense, and you should discuss it, and in that discussion, if it makes sense, that you should go ahead and proceed to do it."

Second, the GOC recommends that, given the lack of evidence, a national study of ovarian cancer prevention through salpingectomy be a priority of the society. "We want to collect the evidence to support this, and we want to be sure that the evidence supports it before we really jump in and say everybody should be doing this," Dr. Rosen said.

"I don’t think there’s any question that salpingectomy makes sense. Serous carcinoma is the worst [ovarian] cancer, it’s the most common cancer, [and] it causes more deaths than any," he commented. "So if you can prevent this cancer, you are probably going to have the biggest impact on ovarian cancer that we have today. Bigger than screening, for sure – we know [screening] doesn’t work. But bigger than any treatment and any of the fancy treatments that are coming out that are really very expensive treatments."

Adding salpingectomy to other, planned surgeries could potentially provide preventive benefit to tens of thousands of women annually in Canada alone. For starters, roughly 47,000 Canadian women undergo hysterectomy nationally each year. Removal of the ovaries and tubes at the same time is fairly standard for those who are postmenopausal. "But it’s the premenopausal women for whom you would have the benefit of taking out the tubes and leaving the ovaries so that they could continue to have their hormone function," he noted.

And the procedure could be offered even more widely. For example, approximately 10,100 new cases of colon cancer are diagnosed annually among Canadian women, many of whom undergo pelvic surgery as a result.

There are many "other situations where urologists or general surgeons are doing surgery, so I don’t think we have to limit this discussion to gynecologists," commented Dr. Rosen. "We need to expand it to all disciplines that may operate in the pelvis, because a surgeon can take out the tubes as well as we can."

When asked by an attendee whether it might perhaps be better to recommend simpler distal salpingectomy instead of total salpingectomy, he expressed reservations.

"While the belief is that most of these cancers arise in the fimbriated end, there are some that do arise further up the tube." Additionally, "we have to be careful if we put in the word ‘distal.’ We also have to define what distal is. So it’s trickier than you think."

Dr. Rosen offered a few notes of caution from his own perspective. "Salpingectomy at open hysterectomy is different than at laparoscopic hysterectomy or tubal ligation," he said. "It’s pretty simple if you have an open case to be able to put your favorite clamp across the tube and remove it; laparascopically, [for some it may be] a little bit more difficult. ... When doing the procedure, you need to treat this as a surgical procedure, and not just think, ‘Oh yeah, we’ll just take out the tubes,’ and find yourself in some trouble with bleeding or an injury of some sort."

Also, the medical profession must decide what level of complications is acceptable. "I don’t know the answer to that, but we need to know what the complication rate is, and we do know that there will be complications," he said.

Finally, the new recommendations are currently based on a hypothesis, not on evidence. "There are other situations in our history in medicine where physicians really believed something very strongly and proceeded with limited information," he noted, citing by way of example the use of diethylstilbestrol in the 1940s and 1950s to prevent miscarriage, and its subsequent linkage to cancer. "We need to be sure that we get the evidence. I believe that we need to evaluate this in some form of clinical trial."

Should salpingectomy prove to be effective and adequately safe for preventing ovarian cancer, it would constitute a major turning point in a disease that still has a poor prognosis, according to Dr. Rosen.

To be sure, treatments have improved steadily over the past 25 years, prolonging life and improving its quality. "We can continue to expect improvements, but I think they are going to be gradual and they are going to be small," he said. "I don’t think anybody would say that there are any home runs out there right now."

Efforts to detect the cancer early through screening have thus far not panned out. Three large screening studies were initiated in 1985-2001, one each in the United Kingdom, Japan, and the United States.

Results from the last – the PLCO (Prostate, Lung, Colorectal, and Ovarian) trial, which tested screening with cancer antigen 125 (CA 125) and transvaginal ultrasound – were recently reported (JAMA 2011;305:2295-303). They showed that 20 surgeries had to be performed to detect one cancer, and the rate of major complications was 20% among patients who underwent surgery. And at the end of the day, there was no reduction in ovarian cancer mortality.

"This is a big study, it is very well done, [and] it has a very long follow-up," Dr. Rosen commented. "And I think this pretty much conclusively says that ultrasound and CA 125 [screening] just don’t work." Results of the U.K. study, which is using a different, serial multimodality approach to screening, are expected in the 2014 timeframe.

Prevention efforts up to this point have been limited to birth control pills and to BRCA testing with prophylactic surgery for carriers, but this group makes up only about a tenth of all patients with ovarian cancer, he noted.

Dr. Rosen said he had no relevant financial disclosures.

VANCOUVER – A clinical trial is needed to assess the risk-benefit profile of salpingectomy for ovarian cancer prevention, said Dr. Barry Rosen.

A recent, serendipitous discovery, resulting from pathology examination of tissues removed during prophylactic salpingo-oophorectomy in patients with BRCA mutations, was that serous "ovarian" cancers actually arise from the fimbriae of the fallopian tubes.

"We didn’t know it when we started doing [the surgery]," Dr. Rosen explained at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. "We sort of all of a sudden started to identify cancers, and most of them were in the tube. ... All of a sudden, there has been a shift in the understanding that serous carcinomas do come from the tube."

In the wake of this new information, the Society of Gynecologic Oncology of Canada (GOC) issued two key recommendations, according to Dr. Rosen, professor of ob.gyn. and head of gynecologic oncology at the University of Toronto.

First, the GOC recommends that physicians discuss the risk-benefit profile of salpingectomy with women who are already having a hysterectomy or seeking irreversible contraception. "We don’t come out and say ‘Do it,’ " he noted. "But we are coming out to say that it makes sense, and you should discuss it, and in that discussion, if it makes sense, that you should go ahead and proceed to do it."

Second, the GOC recommends that, given the lack of evidence, a national study of ovarian cancer prevention through salpingectomy be a priority of the society. "We want to collect the evidence to support this, and we want to be sure that the evidence supports it before we really jump in and say everybody should be doing this," Dr. Rosen said.

"I don’t think there’s any question that salpingectomy makes sense. Serous carcinoma is the worst [ovarian] cancer, it’s the most common cancer, [and] it causes more deaths than any," he commented. "So if you can prevent this cancer, you are probably going to have the biggest impact on ovarian cancer that we have today. Bigger than screening, for sure – we know [screening] doesn’t work. But bigger than any treatment and any of the fancy treatments that are coming out that are really very expensive treatments."

Adding salpingectomy to other, planned surgeries could potentially provide preventive benefit to tens of thousands of women annually in Canada alone. For starters, roughly 47,000 Canadian women undergo hysterectomy nationally each year. Removal of the ovaries and tubes at the same time is fairly standard for those who are postmenopausal. "But it’s the premenopausal women for whom you would have the benefit of taking out the tubes and leaving the ovaries so that they could continue to have their hormone function," he noted.

And the procedure could be offered even more widely. For example, approximately 10,100 new cases of colon cancer are diagnosed annually among Canadian women, many of whom undergo pelvic surgery as a result.

There are many "other situations where urologists or general surgeons are doing surgery, so I don’t think we have to limit this discussion to gynecologists," commented Dr. Rosen. "We need to expand it to all disciplines that may operate in the pelvis, because a surgeon can take out the tubes as well as we can."

When asked by an attendee whether it might perhaps be better to recommend simpler distal salpingectomy instead of total salpingectomy, he expressed reservations.

"While the belief is that most of these cancers arise in the fimbriated end, there are some that do arise further up the tube." Additionally, "we have to be careful if we put in the word ‘distal.’ We also have to define what distal is. So it’s trickier than you think."

Dr. Rosen offered a few notes of caution from his own perspective. "Salpingectomy at open hysterectomy is different than at laparoscopic hysterectomy or tubal ligation," he said. "It’s pretty simple if you have an open case to be able to put your favorite clamp across the tube and remove it; laparascopically, [for some it may be] a little bit more difficult. ... When doing the procedure, you need to treat this as a surgical procedure, and not just think, ‘Oh yeah, we’ll just take out the tubes,’ and find yourself in some trouble with bleeding or an injury of some sort."

Also, the medical profession must decide what level of complications is acceptable. "I don’t know the answer to that, but we need to know what the complication rate is, and we do know that there will be complications," he said.

Finally, the new recommendations are currently based on a hypothesis, not on evidence. "There are other situations in our history in medicine where physicians really believed something very strongly and proceeded with limited information," he noted, citing by way of example the use of diethylstilbestrol in the 1940s and 1950s to prevent miscarriage, and its subsequent linkage to cancer. "We need to be sure that we get the evidence. I believe that we need to evaluate this in some form of clinical trial."

Should salpingectomy prove to be effective and adequately safe for preventing ovarian cancer, it would constitute a major turning point in a disease that still has a poor prognosis, according to Dr. Rosen.

To be sure, treatments have improved steadily over the past 25 years, prolonging life and improving its quality. "We can continue to expect improvements, but I think they are going to be gradual and they are going to be small," he said. "I don’t think anybody would say that there are any home runs out there right now."

Efforts to detect the cancer early through screening have thus far not panned out. Three large screening studies were initiated in 1985-2001, one each in the United Kingdom, Japan, and the United States.

Results from the last – the PLCO (Prostate, Lung, Colorectal, and Ovarian) trial, which tested screening with cancer antigen 125 (CA 125) and transvaginal ultrasound – were recently reported (JAMA 2011;305:2295-303). They showed that 20 surgeries had to be performed to detect one cancer, and the rate of major complications was 20% among patients who underwent surgery. And at the end of the day, there was no reduction in ovarian cancer mortality.

"This is a big study, it is very well done, [and] it has a very long follow-up," Dr. Rosen commented. "And I think this pretty much conclusively says that ultrasound and CA 125 [screening] just don’t work." Results of the U.K. study, which is using a different, serial multimodality approach to screening, are expected in the 2014 timeframe.

Prevention efforts up to this point have been limited to birth control pills and to BRCA testing with prophylactic surgery for carriers, but this group makes up only about a tenth of all patients with ovarian cancer, he noted.

Dr. Rosen said he had no relevant financial disclosures.

VANCOUVER, B.C. – The impact of selective serotonin reuptake inhibitors on fetal pulmonary vascular physiology may boil down to genetics, study results suggest.

In a study of 55 pregnant women who were near term, a variety of right pulmonary artery measures (such as flow and impedance) did not differ significantly between fetuses of women who had been taking SSRIs since conception and those of women who had not. There was also no measurable effect of acute exposure to SSRIs.

However, within the SSRI-exposed group only, fetal right pulmonary artery flow was about 40% higher for infants who experienced respiratory distress in the neonatal period than for their counterparts who did not.

"So there is something different about this particular group in terms of the fact that they developed respiratory distress," commented lead investigator Dr. Kenneth Lim. "Maybe they respond to the SSRIs differently; maybe there is a genetic polymorphism that makes them more susceptible."

Regardless, this difference can be tapped to elucidate the effects of in utero exposure, he added. "It just sort of gives us an idea that maybe we need to look at that a little bit more closely in the next phase of our studies, to try to determine whether there is something going on in the pulmonary system of these babies."

Some 4% of pregnant women in British Columbia are taking SSRIs, according to Dr. Lim of the department of obstetrics and gynecology at the University of British Columbia in Vancouver. "In a province our size, that’s about 1,500-2,000 patients a year who are exposed to SSRIs," he noted at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada.

Previous studies have determined that maternal use of this class of drugs has a variety of deleterious effects on the infant, including low birth weight, prematurity, and a type of withdrawal syndrome characterized by irritability and jitteriness.

"But interestingly, there is also a link with respiratory distress, which tends to be more like a TTN [transient tachypnea of the newborn]-type respiratory distress, and also, there have been case reports of primary pulmonary hypertension," he noted.

The pathogenesis of these pulmonary abnormalities is unclear. "We do know that serotonin itself is a very powerful vasoconstrictor, but it has differential effects in different tissues," Dr. Lim explained.

Preclinically, serotonin impairs lung fluid resorption, suggesting that SSRI-exposed infants may be unable to reabsorb lung fluid after birth; one SSRI has been found to increase arterial smooth muscle cell proliferation.

Pregnant women were eligible for the study if their fetus did not have any anomalies, if they were not taking any illicit or prescription drugs (other than SSRIs), and if they did not have any serious medical conditions.

The investigators enrolled two groups. The nonexposed control group consisted of healthy women who were at low risk for complications and who had not taken SSRIs during pregnancy. The exposed group consisted of women with a mood disorder who had been taking SSRIs since the time of conception.

At a gestational age of about 36 weeks, the women underwent a morning ultrasound exam to assess fetal pulmonary vasculature. Those taking an SSRI then took their medication for the day. In the afternoon, all women had a second ultrasound.

This approach allowed assessment of the effects of both chronic SSRI exposure (by comparing exposed and nonexposed groups) and acute SSRI exposure (by comparing morning and afternoon measurements in the exposed group), Dr. Lim explained.

Results were based on 23 women taking SSRIs (predominantly fluoxetine) and 32 control women. They were 33 years old, on average. Only a single woman in each group smoked during pregnancy. Those in the SSRI group had higher scores for depression.

At delivery, the gestational age was significantly younger in the SSRI-exposed group (39.0 vs. 40.0 weeks). Additionally, the SSRI-exposed infants had a smaller head circumference (34.1 vs. 35.0 cm) and poorer Apgar scores at 1 minute (7.5 vs. 8.4).

Infants in the SSRI-exposed group also were more likely to have respiratory distress (30% vs. 3%) and jitteriness (39% vs. 3%).

"These are all things that have been previously documented, so basically, these kids are behaving the way that we expect from previous studies," commented Dr. Lim.

When it came to fetal right pulmonary artery parameters, there were no significant differences between SSRI-exposed and SSRI-nonexposed groups, or between morning and afternoon within the exposed group, in terms of pulsatility index, resistance index (a measure of blood flow impedance in the artery), peak systolic velocity, diameter, area, and flow.

However, within the SSRI-exposed group, fetal right pulmonary artery flow was higher for infants who experienced respiratory distress in the neonatal period than for those who did not, with a value of approximately 280 mL/min vs. 175 mL/min (P = .03).

Dr. Lim reported no relevant financial disclosures.

VANCOUVER, B.C. – The impact of selective serotonin reuptake inhibitors on fetal pulmonary vascular physiology may boil down to genetics, study results suggest.

In a study of 55 pregnant women who were near term, a variety of right pulmonary artery measures (such as flow and impedance) did not differ significantly between fetuses of women who had been taking SSRIs since conception and those of women who had not. There was also no measurable effect of acute exposure to SSRIs.

However, within the SSRI-exposed group only, fetal right pulmonary artery flow was about 40% higher for infants who experienced respiratory distress in the neonatal period than for their counterparts who did not.

"So there is something different about this particular group in terms of the fact that they developed respiratory distress," commented lead investigator Dr. Kenneth Lim. "Maybe they respond to the SSRIs differently; maybe there is a genetic polymorphism that makes them more susceptible."

Regardless, this difference can be tapped to elucidate the effects of in utero exposure, he added. "It just sort of gives us an idea that maybe we need to look at that a little bit more closely in the next phase of our studies, to try to determine whether there is something going on in the pulmonary system of these babies."

Some 4% of pregnant women in British Columbia are taking SSRIs, according to Dr. Lim of the department of obstetrics and gynecology at the University of British Columbia in Vancouver. "In a province our size, that’s about 1,500-2,000 patients a year who are exposed to SSRIs," he noted at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada.

Previous studies have determined that maternal use of this class of drugs has a variety of deleterious effects on the infant, including low birth weight, prematurity, and a type of withdrawal syndrome characterized by irritability and jitteriness.

"But interestingly, there is also a link with respiratory distress, which tends to be more like a TTN [transient tachypnea of the newborn]-type respiratory distress, and also, there have been case reports of primary pulmonary hypertension," he noted.

The pathogenesis of these pulmonary abnormalities is unclear. "We do know that serotonin itself is a very powerful vasoconstrictor, but it has differential effects in different tissues," Dr. Lim explained.

Preclinically, serotonin impairs lung fluid resorption, suggesting that SSRI-exposed infants may be unable to reabsorb lung fluid after birth; one SSRI has been found to increase arterial smooth muscle cell proliferation.

Pregnant women were eligible for the study if their fetus did not have any anomalies, if they were not taking any illicit or prescription drugs (other than SSRIs), and if they did not have any serious medical conditions.

The investigators enrolled two groups. The nonexposed control group consisted of healthy women who were at low risk for complications and who had not taken SSRIs during pregnancy. The exposed group consisted of women with a mood disorder who had been taking SSRIs since the time of conception.

At a gestational age of about 36 weeks, the women underwent a morning ultrasound exam to assess fetal pulmonary vasculature. Those taking an SSRI then took their medication for the day. In the afternoon, all women had a second ultrasound.

This approach allowed assessment of the effects of both chronic SSRI exposure (by comparing exposed and nonexposed groups) and acute SSRI exposure (by comparing morning and afternoon measurements in the exposed group), Dr. Lim explained.

Results were based on 23 women taking SSRIs (predominantly fluoxetine) and 32 control women. They were 33 years old, on average. Only a single woman in each group smoked during pregnancy. Those in the SSRI group had higher scores for depression.

At delivery, the gestational age was significantly younger in the SSRI-exposed group (39.0 vs. 40.0 weeks). Additionally, the SSRI-exposed infants had a smaller head circumference (34.1 vs. 35.0 cm) and poorer Apgar scores at 1 minute (7.5 vs. 8.4).

Infants in the SSRI-exposed group also were more likely to have respiratory distress (30% vs. 3%) and jitteriness (39% vs. 3%).

"These are all things that have been previously documented, so basically, these kids are behaving the way that we expect from previous studies," commented Dr. Lim.

When it came to fetal right pulmonary artery parameters, there were no significant differences between SSRI-exposed and SSRI-nonexposed groups, or between morning and afternoon within the exposed group, in terms of pulsatility index, resistance index (a measure of blood flow impedance in the artery), peak systolic velocity, diameter, area, and flow.

However, within the SSRI-exposed group, fetal right pulmonary artery flow was higher for infants who experienced respiratory distress in the neonatal period than for those who did not, with a value of approximately 280 mL/min vs. 175 mL/min (P = .03).

Dr. Lim reported no relevant financial disclosures.

VANCOUVER, B.C. – The impact of selective serotonin reuptake inhibitors on fetal pulmonary vascular physiology may boil down to genetics, study results suggest.

In a study of 55 pregnant women who were near term, a variety of right pulmonary artery measures (such as flow and impedance) did not differ significantly between fetuses of women who had been taking SSRIs since conception and those of women who had not. There was also no measurable effect of acute exposure to SSRIs.

However, within the SSRI-exposed group only, fetal right pulmonary artery flow was about 40% higher for infants who experienced respiratory distress in the neonatal period than for their counterparts who did not.

"So there is something different about this particular group in terms of the fact that they developed respiratory distress," commented lead investigator Dr. Kenneth Lim. "Maybe they respond to the SSRIs differently; maybe there is a genetic polymorphism that makes them more susceptible."

Regardless, this difference can be tapped to elucidate the effects of in utero exposure, he added. "It just sort of gives us an idea that maybe we need to look at that a little bit more closely in the next phase of our studies, to try to determine whether there is something going on in the pulmonary system of these babies."

Some 4% of pregnant women in British Columbia are taking SSRIs, according to Dr. Lim of the department of obstetrics and gynecology at the University of British Columbia in Vancouver. "In a province our size, that’s about 1,500-2,000 patients a year who are exposed to SSRIs," he noted at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada.

Previous studies have determined that maternal use of this class of drugs has a variety of deleterious effects on the infant, including low birth weight, prematurity, and a type of withdrawal syndrome characterized by irritability and jitteriness.

"But interestingly, there is also a link with respiratory distress, which tends to be more like a TTN [transient tachypnea of the newborn]-type respiratory distress, and also, there have been case reports of primary pulmonary hypertension," he noted.

The pathogenesis of these pulmonary abnormalities is unclear. "We do know that serotonin itself is a very powerful vasoconstrictor, but it has differential effects in different tissues," Dr. Lim explained.

Preclinically, serotonin impairs lung fluid resorption, suggesting that SSRI-exposed infants may be unable to reabsorb lung fluid after birth; one SSRI has been found to increase arterial smooth muscle cell proliferation.

Pregnant women were eligible for the study if their fetus did not have any anomalies, if they were not taking any illicit or prescription drugs (other than SSRIs), and if they did not have any serious medical conditions.

The investigators enrolled two groups. The nonexposed control group consisted of healthy women who were at low risk for complications and who had not taken SSRIs during pregnancy. The exposed group consisted of women with a mood disorder who had been taking SSRIs since the time of conception.

At a gestational age of about 36 weeks, the women underwent a morning ultrasound exam to assess fetal pulmonary vasculature. Those taking an SSRI then took their medication for the day. In the afternoon, all women had a second ultrasound.

This approach allowed assessment of the effects of both chronic SSRI exposure (by comparing exposed and nonexposed groups) and acute SSRI exposure (by comparing morning and afternoon measurements in the exposed group), Dr. Lim explained.

Results were based on 23 women taking SSRIs (predominantly fluoxetine) and 32 control women. They were 33 years old, on average. Only a single woman in each group smoked during pregnancy. Those in the SSRI group had higher scores for depression.

At delivery, the gestational age was significantly younger in the SSRI-exposed group (39.0 vs. 40.0 weeks). Additionally, the SSRI-exposed infants had a smaller head circumference (34.1 vs. 35.0 cm) and poorer Apgar scores at 1 minute (7.5 vs. 8.4).

Infants in the SSRI-exposed group also were more likely to have respiratory distress (30% vs. 3%) and jitteriness (39% vs. 3%).

"These are all things that have been previously documented, so basically, these kids are behaving the way that we expect from previous studies," commented Dr. Lim.

When it came to fetal right pulmonary artery parameters, there were no significant differences between SSRI-exposed and SSRI-nonexposed groups, or between morning and afternoon within the exposed group, in terms of pulsatility index, resistance index (a measure of blood flow impedance in the artery), peak systolic velocity, diameter, area, and flow.

However, within the SSRI-exposed group, fetal right pulmonary artery flow was higher for infants who experienced respiratory distress in the neonatal period than for those who did not, with a value of approximately 280 mL/min vs. 175 mL/min (P = .03).

Dr. Lim reported no relevant financial disclosures.

VANCOUVER, B.C. – An ultrasound diagnosis of fetal macrosomia at term is inaccurate in the majority of cases, and this inaccuracy may be contributing to unnecessary cesarean deliveries, new data suggest.

In an observational cohort study of 235 pregnancies at term in which ultrasound measurements led to a diagnosis of fetal macrosomia, only about a third of the infants were actually macrosomic at birth. Additionally, these pregnancies with ultrasound-diagnosed fetal macrosomia were more than twice as likely as all pregnancies in the population to end in cesarean delivery, according to results reported at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada.

Ultrasound-estimated fetal weight "is not very accurate, and we have to counsel patients on that, when they come to ultrasounds and they are worried that they are going to have this [enormous] monstrosity of a baby," lead investigator Dr. Alese Wagner said in an interview. "You can tell them [that] most of the time, we are off."

She further recommended that physicians keep this new information in mind when it comes to recommending delivery interventions for a pregnancy in which the ultrasound suggests macrosomia.

Surprisingly, the accuracy of ultrasound in assessing fetal weight is similar to that found with simple clinical palpation, according to Dr. Wagner, a third-year resident in the department of obstetrics and gynecology at the University of Calgary in Alberta.

The study used the Hadlock formula for calculating weight from ultrasound fetal measurements, "which is supposed to be one of the better formulas for macrosomic infants," she noted.

"Interestingly enough, people have shown that through the years, as the technology has gotten better – these ultrasound machines that we have now are amazing, what they can do – this [accuracy] hasn’t gotten better," she added, speculating that the disconnect may in part be the result of reliance on simple measurements that don’t take into account tissue densities.

Additionally, ultrasound assessment late in pregnancy is inherently more difficult because the fetus is so low in the pelvis and there is less amniotic fluid. Maternal body habitus also may play a role.

Using the clinical database of a tertiary referral center for the years 2005-2009, Dr. Wagner and her coinvestigators identified 235 women who had an ultrasound exam within 2 weeks of delivery that indicated the presence of fetal macrosomia (defined as an estimated fetal weight of at least 4,500 g, as calculated via the Hadlock formula).

However, they found that at the time of delivery, just 88 of these infants had an actual birth weight of at least 4,500 g, for a positive predictive value of merely 37.4%, according to results reported in a poster session.

"It looked like most of the providers were overestimating weight," she observed; the median estimated fetal weight was 4,693 g, whereas the median birth weight was 4,368 g.

The mean percentage error of the estimated fetal weight was 8.6% overall. Viewed another way, 44% of the weights were off by more than 10%, and 7% were off by more than 20%.

There were only weak correlations between estimated fetal weight and birth weight, as well as between the individual fetal measurements used in the Hadlock formula and birth weight.

The mode of delivery was cesarean section in 66% of the pregnancies, compared with just 29% of all pregnancies in Calgary during the same period. "So it’s [more than] double, the percentage who are getting C-sections, on what is [an inaccurate weight]," said Dr. Wagner.

Before the study, "there was a general feeling that we were pretty [far off] in the estimates of the fetal weights that we were getting closer to term, especially for the bigger babies," she commented. "People ... usually thought that they were overestimating them, so it was nice to actually look at ... what the actual numbers were."

"This opens up a lot of other areas that we can explore more within just this study," such as whether maternal body mass index is affecting ultrasound accuracy, Dr. Wagner concluded. "So this is kind of a starting project."

Dr. Wagner reported that she had no relevant financial disclosures.

VANCOUVER, B.C. – An ultrasound diagnosis of fetal macrosomia at term is inaccurate in the majority of cases, and this inaccuracy may be contributing to unnecessary cesarean deliveries, new data suggest.

In an observational cohort study of 235 pregnancies at term in which ultrasound measurements led to a diagnosis of fetal macrosomia, only about a third of the infants were actually macrosomic at birth. Additionally, these pregnancies with ultrasound-diagnosed fetal macrosomia were more than twice as likely as all pregnancies in the population to end in cesarean delivery, according to results reported at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada.

Ultrasound-estimated fetal weight "is not very accurate, and we have to counsel patients on that, when they come to ultrasounds and they are worried that they are going to have this [enormous] monstrosity of a baby," lead investigator Dr. Alese Wagner said in an interview. "You can tell them [that] most of the time, we are off."

She further recommended that physicians keep this new information in mind when it comes to recommending delivery interventions for a pregnancy in which the ultrasound suggests macrosomia.

Surprisingly, the accuracy of ultrasound in assessing fetal weight is similar to that found with simple clinical palpation, according to Dr. Wagner, a third-year resident in the department of obstetrics and gynecology at the University of Calgary in Alberta.

The study used the Hadlock formula for calculating weight from ultrasound fetal measurements, "which is supposed to be one of the better formulas for macrosomic infants," she noted.

"Interestingly enough, people have shown that through the years, as the technology has gotten better – these ultrasound machines that we have now are amazing, what they can do – this [accuracy] hasn’t gotten better," she added, speculating that the disconnect may in part be the result of reliance on simple measurements that don’t take into account tissue densities.

Additionally, ultrasound assessment late in pregnancy is inherently more difficult because the fetus is so low in the pelvis and there is less amniotic fluid. Maternal body habitus also may play a role.

Using the clinical database of a tertiary referral center for the years 2005-2009, Dr. Wagner and her coinvestigators identified 235 women who had an ultrasound exam within 2 weeks of delivery that indicated the presence of fetal macrosomia (defined as an estimated fetal weight of at least 4,500 g, as calculated via the Hadlock formula).

However, they found that at the time of delivery, just 88 of these infants had an actual birth weight of at least 4,500 g, for a positive predictive value of merely 37.4%, according to results reported in a poster session.

"It looked like most of the providers were overestimating weight," she observed; the median estimated fetal weight was 4,693 g, whereas the median birth weight was 4,368 g.

The mean percentage error of the estimated fetal weight was 8.6% overall. Viewed another way, 44% of the weights were off by more than 10%, and 7% were off by more than 20%.

There were only weak correlations between estimated fetal weight and birth weight, as well as between the individual fetal measurements used in the Hadlock formula and birth weight.

The mode of delivery was cesarean section in 66% of the pregnancies, compared with just 29% of all pregnancies in Calgary during the same period. "So it’s [more than] double, the percentage who are getting C-sections, on what is [an inaccurate weight]," said Dr. Wagner.

Before the study, "there was a general feeling that we were pretty [far off] in the estimates of the fetal weights that we were getting closer to term, especially for the bigger babies," she commented. "People ... usually thought that they were overestimating them, so it was nice to actually look at ... what the actual numbers were."

"This opens up a lot of other areas that we can explore more within just this study," such as whether maternal body mass index is affecting ultrasound accuracy, Dr. Wagner concluded. "So this is kind of a starting project."

Dr. Wagner reported that she had no relevant financial disclosures.

VANCOUVER, B.C. – An ultrasound diagnosis of fetal macrosomia at term is inaccurate in the majority of cases, and this inaccuracy may be contributing to unnecessary cesarean deliveries, new data suggest.

In an observational cohort study of 235 pregnancies at term in which ultrasound measurements led to a diagnosis of fetal macrosomia, only about a third of the infants were actually macrosomic at birth. Additionally, these pregnancies with ultrasound-diagnosed fetal macrosomia were more than twice as likely as all pregnancies in the population to end in cesarean delivery, according to results reported at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada.

Ultrasound-estimated fetal weight "is not very accurate, and we have to counsel patients on that, when they come to ultrasounds and they are worried that they are going to have this [enormous] monstrosity of a baby," lead investigator Dr. Alese Wagner said in an interview. "You can tell them [that] most of the time, we are off."

She further recommended that physicians keep this new information in mind when it comes to recommending delivery interventions for a pregnancy in which the ultrasound suggests macrosomia.

Surprisingly, the accuracy of ultrasound in assessing fetal weight is similar to that found with simple clinical palpation, according to Dr. Wagner, a third-year resident in the department of obstetrics and gynecology at the University of Calgary in Alberta.

The study used the Hadlock formula for calculating weight from ultrasound fetal measurements, "which is supposed to be one of the better formulas for macrosomic infants," she noted.

"Interestingly enough, people have shown that through the years, as the technology has gotten better – these ultrasound machines that we have now are amazing, what they can do – this [accuracy] hasn’t gotten better," she added, speculating that the disconnect may in part be the result of reliance on simple measurements that don’t take into account tissue densities.

Additionally, ultrasound assessment late in pregnancy is inherently more difficult because the fetus is so low in the pelvis and there is less amniotic fluid. Maternal body habitus also may play a role.

Using the clinical database of a tertiary referral center for the years 2005-2009, Dr. Wagner and her coinvestigators identified 235 women who had an ultrasound exam within 2 weeks of delivery that indicated the presence of fetal macrosomia (defined as an estimated fetal weight of at least 4,500 g, as calculated via the Hadlock formula).

However, they found that at the time of delivery, just 88 of these infants had an actual birth weight of at least 4,500 g, for a positive predictive value of merely 37.4%, according to results reported in a poster session.

"It looked like most of the providers were overestimating weight," she observed; the median estimated fetal weight was 4,693 g, whereas the median birth weight was 4,368 g.

The mean percentage error of the estimated fetal weight was 8.6% overall. Viewed another way, 44% of the weights were off by more than 10%, and 7% were off by more than 20%.

There were only weak correlations between estimated fetal weight and birth weight, as well as between the individual fetal measurements used in the Hadlock formula and birth weight.

The mode of delivery was cesarean section in 66% of the pregnancies, compared with just 29% of all pregnancies in Calgary during the same period. "So it’s [more than] double, the percentage who are getting C-sections, on what is [an inaccurate weight]," said Dr. Wagner.

Before the study, "there was a general feeling that we were pretty [far off] in the estimates of the fetal weights that we were getting closer to term, especially for the bigger babies," she commented. "People ... usually thought that they were overestimating them, so it was nice to actually look at ... what the actual numbers were."

"This opens up a lot of other areas that we can explore more within just this study," such as whether maternal body mass index is affecting ultrasound accuracy, Dr. Wagner concluded. "So this is kind of a starting project."

Dr. Wagner reported that she had no relevant financial disclosures.

VANCOUVER, B.C. – Use of tampons or menstrual cups does not increase the risk of early expulsion of an intrauterine device, according to findings of a retrospective cohort study of nearly 1,000 women.

In the study, the overall rate of IUD expulsion within 2 months of insertion was low (3.5%), and was statistically no higher for women who used tampons or cups than it was for their counterparts who used pads.

"Women can be reassured that they can use whatever their usual menstrual product is and not increase their risk of expelling the IUD," said coinvestigator Dr. Ellen Wiebe of the department of family practice at the University of British Columbia, Vancouver.

She noted that it is a common concern that vaginal menstrual products will tug on the IUD strings protruding from the cervix, thereby pulling the device out. And most IUD expulsions in the first year occur within a month of insertion (Hum. Reprod. Update 2008;14:197-208).

"Every day, I would get asked the question, ‘Is it okay to use tampons with the IUD?’ And every week or so, I would get asked the question, ‘Is it okay to use a cup with the IUD?’ " she said in an interview at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. "And I looked in the literature, and there were no answers."

Moreover, IUD package inserts are inconsistent on the issue. For example, of the four IUDs on the market in Canada, the Mirena package insert says that tampons can be used, the Liberté insert notes that tampons can be used (but is silent on the use of menstrual cups), and the Flexi-T and Nova-T inserts do not mention menstrual products at all, she said.

She further noted that little is known about the prevalence of menstrual cup use today, as most studies on this product were done in the 1960s and focused on acceptability.

Dr. Wiebe and her colleague retrospectively reviewed the charts of 999 women who underwent IUD insertion at two reproductive health clinics in 2009.

Study results, reported in a poster session at the meeting, showed that about half the women had the hormonal Mirena IUD inserted and about half had one of the copper IUDs inserted. Among the 930 women having data on the type of menstrual product used, 74% used tampons, 43% used pads, and 10% used menstrual cups, with many using more than one product.

Cup users were more likely than pad users and tampon users to be younger than 30 years of age (77% vs. 51% and 61%, respectively) and nulliparous (88% vs. 54% and 69%, respectively). Additionally, cup users were more likely than pad users to be white (85% vs. 69%).

Among the 620 women who had adequate follow-up, the rate of early IUD expulsion (defined as within 2 months of insertion) was 3.5% overall, and was statistically indistinguishable among women who used pads (4%), tampons (2%), and menstrual cups (6%).

Based on anecdotal evidence, "I knew it was fine, and most of our colleagues thought it was fine" to use tampons and menstrual cups with an IUD, said Dr. Wiebe.

"But that’s not the evidence you want to give your patient," she added. "You’d rather say, ‘Well, we looked at 1,000 women and it didn’t make any difference what they used.’ "

Dr. Wiebe reported that she had no relevant conflicts of interest.

VANCOUVER, B.C. – Use of tampons or menstrual cups does not increase the risk of early expulsion of an intrauterine device, according to findings of a retrospective cohort study of nearly 1,000 women.

In the study, the overall rate of IUD expulsion within 2 months of insertion was low (3.5%), and was statistically no higher for women who used tampons or cups than it was for their counterparts who used pads.

"Women can be reassured that they can use whatever their usual menstrual product is and not increase their risk of expelling the IUD," said coinvestigator Dr. Ellen Wiebe of the department of family practice at the University of British Columbia, Vancouver.

She noted that it is a common concern that vaginal menstrual products will tug on the IUD strings protruding from the cervix, thereby pulling the device out. And most IUD expulsions in the first year occur within a month of insertion (Hum. Reprod. Update 2008;14:197-208).

"Every day, I would get asked the question, ‘Is it okay to use tampons with the IUD?’ And every week or so, I would get asked the question, ‘Is it okay to use a cup with the IUD?’ " she said in an interview at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. "And I looked in the literature, and there were no answers."

Moreover, IUD package inserts are inconsistent on the issue. For example, of the four IUDs on the market in Canada, the Mirena package insert says that tampons can be used, the Liberté insert notes that tampons can be used (but is silent on the use of menstrual cups), and the Flexi-T and Nova-T inserts do not mention menstrual products at all, she said.

She further noted that little is known about the prevalence of menstrual cup use today, as most studies on this product were done in the 1960s and focused on acceptability.

Dr. Wiebe and her colleague retrospectively reviewed the charts of 999 women who underwent IUD insertion at two reproductive health clinics in 2009.

Study results, reported in a poster session at the meeting, showed that about half the women had the hormonal Mirena IUD inserted and about half had one of the copper IUDs inserted. Among the 930 women having data on the type of menstrual product used, 74% used tampons, 43% used pads, and 10% used menstrual cups, with many using more than one product.

Cup users were more likely than pad users and tampon users to be younger than 30 years of age (77% vs. 51% and 61%, respectively) and nulliparous (88% vs. 54% and 69%, respectively). Additionally, cup users were more likely than pad users to be white (85% vs. 69%).

Among the 620 women who had adequate follow-up, the rate of early IUD expulsion (defined as within 2 months of insertion) was 3.5% overall, and was statistically indistinguishable among women who used pads (4%), tampons (2%), and menstrual cups (6%).

Based on anecdotal evidence, "I knew it was fine, and most of our colleagues thought it was fine" to use tampons and menstrual cups with an IUD, said Dr. Wiebe.

"But that’s not the evidence you want to give your patient," she added. "You’d rather say, ‘Well, we looked at 1,000 women and it didn’t make any difference what they used.’ "

Dr. Wiebe reported that she had no relevant conflicts of interest.

VANCOUVER, B.C. – Use of tampons or menstrual cups does not increase the risk of early expulsion of an intrauterine device, according to findings of a retrospective cohort study of nearly 1,000 women.

In the study, the overall rate of IUD expulsion within 2 months of insertion was low (3.5%), and was statistically no higher for women who used tampons or cups than it was for their counterparts who used pads.

"Women can be reassured that they can use whatever their usual menstrual product is and not increase their risk of expelling the IUD," said coinvestigator Dr. Ellen Wiebe of the department of family practice at the University of British Columbia, Vancouver.

She noted that it is a common concern that vaginal menstrual products will tug on the IUD strings protruding from the cervix, thereby pulling the device out. And most IUD expulsions in the first year occur within a month of insertion (Hum. Reprod. Update 2008;14:197-208).

"Every day, I would get asked the question, ‘Is it okay to use tampons with the IUD?’ And every week or so, I would get asked the question, ‘Is it okay to use a cup with the IUD?’ " she said in an interview at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. "And I looked in the literature, and there were no answers."

Moreover, IUD package inserts are inconsistent on the issue. For example, of the four IUDs on the market in Canada, the Mirena package insert says that tampons can be used, the Liberté insert notes that tampons can be used (but is silent on the use of menstrual cups), and the Flexi-T and Nova-T inserts do not mention menstrual products at all, she said.

She further noted that little is known about the prevalence of menstrual cup use today, as most studies on this product were done in the 1960s and focused on acceptability.

Dr. Wiebe and her colleague retrospectively reviewed the charts of 999 women who underwent IUD insertion at two reproductive health clinics in 2009.

Study results, reported in a poster session at the meeting, showed that about half the women had the hormonal Mirena IUD inserted and about half had one of the copper IUDs inserted. Among the 930 women having data on the type of menstrual product used, 74% used tampons, 43% used pads, and 10% used menstrual cups, with many using more than one product.

Cup users were more likely than pad users and tampon users to be younger than 30 years of age (77% vs. 51% and 61%, respectively) and nulliparous (88% vs. 54% and 69%, respectively). Additionally, cup users were more likely than pad users to be white (85% vs. 69%).

Among the 620 women who had adequate follow-up, the rate of early IUD expulsion (defined as within 2 months of insertion) was 3.5% overall, and was statistically indistinguishable among women who used pads (4%), tampons (2%), and menstrual cups (6%).

Based on anecdotal evidence, "I knew it was fine, and most of our colleagues thought it was fine" to use tampons and menstrual cups with an IUD, said Dr. Wiebe.

"But that’s not the evidence you want to give your patient," she added. "You’d rather say, ‘Well, we looked at 1,000 women and it didn’t make any difference what they used.’ "

Dr. Wiebe reported that she had no relevant conflicts of interest.

DENVER – Patients with chronic obstructive pulmonary disease have a slower decline in lung function, fewer exacerbations, and a marginally reduced risk of death if treated with anti-inflammatory agents. But the association between COPD and inflammation is hardly straightforward.

These were among the key messages that Dr. Alvar Agusti, director of the Thorax Institute, Hospital Clinic, University of Barcelona, imparted to attendees of the international conference of the American Thoracic Society.

Although "without an appropriate inflammatory response, we would all be dead quickly," inflammation is complex, he said. "There is a part of the inflammatory response that tries to kill or stop the injury, but there is another part that tries to restore the tissue structure and function. So there is both good and bad inflammation."

COPD clearly has a pulmonary inflammatory component. In addition, "it is well known and well established over the past few years that there is also systemic inflammation, and that this systematic inflammation may explain some of the extrapulmonary manifestations of the disease," Dr. Agusti noted.

A study among patients with COPD has shown that the number of inflammatory cells in the small airways increases with disease severity (N. Engl. J. Med. 2004;350:2645-53). But because the study was cross-sectional, "we do not really know if inflammation is driving disease progression, if it is vice versa, or both in a closed loop," he commented.

Also, it is unclear whether this is good or bad inflammation. For example, "all of us are aware that in some patients with COPD, there may be some consequences of interfering with the inflammatory response, such as an increased rate of pneumonia. ... This is clearly something that we need to understand better in relation to the inflammatory response," he observed.

"The evidence we have in vivo supports the effectiveness of anti-inflammatory therapy in COPD when combined with bronchodilator therapy," Dr. Agusti said.

For example, among patients with moderate to severe COPD, bronchial biopsies show that compared with placebo, the combination of fluticasone and salmeterol (a long-acting beta-agonist) has an anti-inflammatory effect at the cellular level, reducing numbers of macrophages, mast cells, and CD4 cells, among others (Am. J. Respir. Crit. Care Med. 2006;173:736-43).

When it comes to clinical outcomes, patients given budesonide plus formoterol with tiotropium have fewer exacerbations than their peers given placebo with tiotropium (Am. J. Respir. Crit. Care Med. 2009;180:741-50).

And in the large TORCH (Towards a Revolution in COPD Health) trial among patients with COPD, the rate of decline of forced expiratory volume in 1 second (FEV₁) was slower in patients given fluticasone and salmeterol than in their peers given a placebo (Am. J. Respir. Crit. Care Med. 2008;178:332-8). Mortality, the trial’s primary outcome, also was marginally lower (hazard ratio, 0.825; P = .052) (N. Engl. J. Med. 2007;356:775-89).

"It’s up to us clinicians to decide whether there is or is not a significant effect on survival," Dr. Agusti said. "However, TORCH also showed us that there are very clear effects ... in the clinic, in patients, when we use anti-inflammatory therapy." For example, health status as measured with the St. George’s Respiratory Questionnaire was better in the group given fluticasone plus salmeterol.

Finally, a newer oral NSAID, roflumilast, has been shown to reduce exacerbations in patients with moderate to severe COPD when added to salmeterol or tiotropium (Lancet 2009;374:695-703).

"We have to consider that inflammation is a vital but extraordinarily complex biological response," Dr. Agusti concluded. "And we need to understand much better the types of inflammation and how they vary between different COPD phenotypes."

Indeed, in the future, inflammatory status may be used to individualize therapy. "Why would you want to use an anti-inflammatory drug in someone who has no inflammation? But this is what we have been doing so far – we are just prescribing based on FEV₁ and symptoms," he said. "If we really want to move toward more personalized medicine, somehow – I do not know how, but somehow – we will have to phenotype our patients better. And inflammation seems like a very good candidate to do this."

Dr. Agusti reported being an adviser to, speaker for, or receiving research funding from Almirall, Astra-Zeneca, Boehringer Ingelheim, Chiessi, GlaxoSmithKline, Esteve, MSD, Nycomed, Novartis, Pfizer, Roche, and Procter & Gamble.

DENVER – Patients with chronic obstructive pulmonary disease have a slower decline in lung function, fewer exacerbations, and a marginally reduced risk of death if treated with anti-inflammatory agents. But the association between COPD and inflammation is hardly straightforward.

These were among the key messages that Dr. Alvar Agusti, director of the Thorax Institute, Hospital Clinic, University of Barcelona, imparted to attendees of the international conference of the American Thoracic Society.

Although "without an appropriate inflammatory response, we would all be dead quickly," inflammation is complex, he said. "There is a part of the inflammatory response that tries to kill or stop the injury, but there is another part that tries to restore the tissue structure and function. So there is both good and bad inflammation."

COPD clearly has a pulmonary inflammatory component. In addition, "it is well known and well established over the past few years that there is also systemic inflammation, and that this systematic inflammation may explain some of the extrapulmonary manifestations of the disease," Dr. Agusti noted.

A study among patients with COPD has shown that the number of inflammatory cells in the small airways increases with disease severity (N. Engl. J. Med. 2004;350:2645-53). But because the study was cross-sectional, "we do not really know if inflammation is driving disease progression, if it is vice versa, or both in a closed loop," he commented.

Also, it is unclear whether this is good or bad inflammation. For example, "all of us are aware that in some patients with COPD, there may be some consequences of interfering with the inflammatory response, such as an increased rate of pneumonia. ... This is clearly something that we need to understand better in relation to the inflammatory response," he observed.

"The evidence we have in vivo supports the effectiveness of anti-inflammatory therapy in COPD when combined with bronchodilator therapy," Dr. Agusti said.

For example, among patients with moderate to severe COPD, bronchial biopsies show that compared with placebo, the combination of fluticasone and salmeterol (a long-acting beta-agonist) has an anti-inflammatory effect at the cellular level, reducing numbers of macrophages, mast cells, and CD4 cells, among others (Am. J. Respir. Crit. Care Med. 2006;173:736-43).

When it comes to clinical outcomes, patients given budesonide plus formoterol with tiotropium have fewer exacerbations than their peers given placebo with tiotropium (Am. J. Respir. Crit. Care Med. 2009;180:741-50).

And in the large TORCH (Towards a Revolution in COPD Health) trial among patients with COPD, the rate of decline of forced expiratory volume in 1 second (FEV₁) was slower in patients given fluticasone and salmeterol than in their peers given a placebo (Am. J. Respir. Crit. Care Med. 2008;178:332-8). Mortality, the trial’s primary outcome, also was marginally lower (hazard ratio, 0.825; P = .052) (N. Engl. J. Med. 2007;356:775-89).

"It’s up to us clinicians to decide whether there is or is not a significant effect on survival," Dr. Agusti said. "However, TORCH also showed us that there are very clear effects ... in the clinic, in patients, when we use anti-inflammatory therapy." For example, health status as measured with the St. George’s Respiratory Questionnaire was better in the group given fluticasone plus salmeterol.

Finally, a newer oral NSAID, roflumilast, has been shown to reduce exacerbations in patients with moderate to severe COPD when added to salmeterol or tiotropium (Lancet 2009;374:695-703).

"We have to consider that inflammation is a vital but extraordinarily complex biological response," Dr. Agusti concluded. "And we need to understand much better the types of inflammation and how they vary between different COPD phenotypes."

Indeed, in the future, inflammatory status may be used to individualize therapy. "Why would you want to use an anti-inflammatory drug in someone who has no inflammation? But this is what we have been doing so far – we are just prescribing based on FEV₁ and symptoms," he said. "If we really want to move toward more personalized medicine, somehow – I do not know how, but somehow – we will have to phenotype our patients better. And inflammation seems like a very good candidate to do this."

Dr. Agusti reported being an adviser to, speaker for, or receiving research funding from Almirall, Astra-Zeneca, Boehringer Ingelheim, Chiessi, GlaxoSmithKline, Esteve, MSD, Nycomed, Novartis, Pfizer, Roche, and Procter & Gamble.

DENVER – Patients with chronic obstructive pulmonary disease have a slower decline in lung function, fewer exacerbations, and a marginally reduced risk of death if treated with anti-inflammatory agents. But the association between COPD and inflammation is hardly straightforward.

These were among the key messages that Dr. Alvar Agusti, director of the Thorax Institute, Hospital Clinic, University of Barcelona, imparted to attendees of the international conference of the American Thoracic Society.

Although "without an appropriate inflammatory response, we would all be dead quickly," inflammation is complex, he said. "There is a part of the inflammatory response that tries to kill or stop the injury, but there is another part that tries to restore the tissue structure and function. So there is both good and bad inflammation."

COPD clearly has a pulmonary inflammatory component. In addition, "it is well known and well established over the past few years that there is also systemic inflammation, and that this systematic inflammation may explain some of the extrapulmonary manifestations of the disease," Dr. Agusti noted.

A study among patients with COPD has shown that the number of inflammatory cells in the small airways increases with disease severity (N. Engl. J. Med. 2004;350:2645-53). But because the study was cross-sectional, "we do not really know if inflammation is driving disease progression, if it is vice versa, or both in a closed loop," he commented.

Also, it is unclear whether this is good or bad inflammation. For example, "all of us are aware that in some patients with COPD, there may be some consequences of interfering with the inflammatory response, such as an increased rate of pneumonia. ... This is clearly something that we need to understand better in relation to the inflammatory response," he observed.

"The evidence we have in vivo supports the effectiveness of anti-inflammatory therapy in COPD when combined with bronchodilator therapy," Dr. Agusti said.

For example, among patients with moderate to severe COPD, bronchial biopsies show that compared with placebo, the combination of fluticasone and salmeterol (a long-acting beta-agonist) has an anti-inflammatory effect at the cellular level, reducing numbers of macrophages, mast cells, and CD4 cells, among others (Am. J. Respir. Crit. Care Med. 2006;173:736-43).

When it comes to clinical outcomes, patients given budesonide plus formoterol with tiotropium have fewer exacerbations than their peers given placebo with tiotropium (Am. J. Respir. Crit. Care Med. 2009;180:741-50).

And in the large TORCH (Towards a Revolution in COPD Health) trial among patients with COPD, the rate of decline of forced expiratory volume in 1 second (FEV₁) was slower in patients given fluticasone and salmeterol than in their peers given a placebo (Am. J. Respir. Crit. Care Med. 2008;178:332-8). Mortality, the trial’s primary outcome, also was marginally lower (hazard ratio, 0.825; P = .052) (N. Engl. J. Med. 2007;356:775-89).

"It’s up to us clinicians to decide whether there is or is not a significant effect on survival," Dr. Agusti said. "However, TORCH also showed us that there are very clear effects ... in the clinic, in patients, when we use anti-inflammatory therapy." For example, health status as measured with the St. George’s Respiratory Questionnaire was better in the group given fluticasone plus salmeterol.

Finally, a newer oral NSAID, roflumilast, has been shown to reduce exacerbations in patients with moderate to severe COPD when added to salmeterol or tiotropium (Lancet 2009;374:695-703).

"We have to consider that inflammation is a vital but extraordinarily complex biological response," Dr. Agusti concluded. "And we need to understand much better the types of inflammation and how they vary between different COPD phenotypes."

Indeed, in the future, inflammatory status may be used to individualize therapy. "Why would you want to use an anti-inflammatory drug in someone who has no inflammation? But this is what we have been doing so far – we are just prescribing based on FEV₁ and symptoms," he said. "If we really want to move toward more personalized medicine, somehow – I do not know how, but somehow – we will have to phenotype our patients better. And inflammation seems like a very good candidate to do this."

Dr. Agusti reported being an adviser to, speaker for, or receiving research funding from Almirall, Astra-Zeneca, Boehringer Ingelheim, Chiessi, GlaxoSmithKline, Esteve, MSD, Nycomed, Novartis, Pfizer, Roche, and Procter & Gamble.

VANCOUVER, B.C. – The risk of congenital anomalies for a given pregnancy varies according to the time elapsed since the last pregnancy, a retrospective population-based cohort study of more than 46,000 women has shown.

Study results, reported at the meeting, showed that the rate of congenital anomalies was lowest when the interpregnancy interval was 12–17 months and increased with both shorter and longer intervals. The pattern was similar for folate-dependent and folate-independent anomalies individually.

“A J-shaped relationship exists between interpregnancy interval and congenital anomalies,” said principal investigator Dr. Innie Chen, a resident in the department of obstetrics and gynecology at the University of Alberta, Edmonton. “The observation that long intervals were associated with congenital anomalies as well as the preservation of the association for folate-independent anomalies suggests that the mechanism of the observed effect is unlikely to be mediated by folate deficiency alone.

“To date and to our knowledge, this is the most comprehensive data available on this topic. The implications of this study are broad and touch on prenatal risk assessment, prenatal counseling, and future recommendations regarding birth spacing and nutritional supplementation,” she said.

But she also cautioned that it could be problematic to apply the findings to individual women who ask when is the best time to conceive again to minimize risk.

“This is an epidemiological study. Decisions for individuals depend on a lot of things, such as where they are in their life and their career situation,” she explained. “But I think this data adds to the growing literature about the effect of interpregnancy interval and adverse perinatal outcomes, which we see again and again. Compared to 50 or 100 years ago, we have much better contraception, so I think it is within our control.”

A variety of adverse perinatal outcomes – preterm birth, small for gestational age, low birth weight, and perinatal death – have shown a J-shaped association with interpregnancy interval.

“The most-often-cited postulated mechanism for the observed effect is a folate-deficiency hypothesis, which is based on the observation that maternal serum levels are very low in the postpartum period,” Dr. Chen said.

A previous retrospective cohort study found an association between both short and long interpregnancy intervals and major congenital malformations (Contraception 2009;80:512–8). But that study did not evaluate specific types of anomalies.

Dr. Chen and her colleagues began with data from the Alberta Perinatal Health Program Database, which collects information on all hospital and midwife births, and all terminations after 20 weeks' gestation in the Northern part of the province.

They identified women who had a singleton delivery between 1999 and 2007 (the post–folate food fortification era, so that results would be applicable today) and who did not have a miscarriage between their first and second births (so that the interpregnancy interval was more reliable).

They then linked that data with data from other provincial databases to obtain more comprehensive maternal information and ascertain anomalies.

The working data set consisted of 46,559 pregnant women. The interpregnancy interval was 6–59 weeks' gestation for 90% of them.

Most of the women were 20–34 years old (83%) and para 2 (88%) at the time of the second delivery, and most of their infants had a gestational age of at least 37 weeks (93%) and a birth weight of at least 2,500 g (96%).

The rate of congenital anomalies did not vary significantly according to maternal age, maternal weight, smoking in pregnancy, or socioeconomic status, Dr. Chen reported.

For interpregnancy intervals of 59 months or less, there was a J-shaped association between the interval and the rate of congenital anomalies. The rate was lowest, at 1.9%, when the interval was 12–17 months.

It rose to a high of 2.5% when the interval was 0–5 months and 2.4% when the interval was 24–59 months. The corresponding odds ratios were 1.35 and 1.28, respectively.

The pattern was similar for folate-dependent anomalies (neural tube defects, cleft lip and palate, cardiovascular defects, urinary tract anomalies, and limb defects) and for folate-independent anomalies individually.

In addition, an interval of 0–5 months was associated with increased odds of specific anomalies, such as neural tube defects and heart defects, but not significantly so.

“We believe these results to be valid as they are consistent with and corroborate existing studies in the literature,” said Dr. Chen.

“Future directions for research include changing the databases to capture more information on all terminations and folate supplementation, combining the databases for more statistical power, and checking other postulated mechanisms for the observed effect,” she said.

VANCOUVER, B.C. – The risk of congenital anomalies for a given pregnancy varies according to the time elapsed since the last pregnancy, a retrospective population-based cohort study of more than 46,000 women has shown.

Study results, reported at the meeting, showed that the rate of congenital anomalies was lowest when the interpregnancy interval was 12–17 months and increased with both shorter and longer intervals. The pattern was similar for folate-dependent and folate-independent anomalies individually.

“A J-shaped relationship exists between interpregnancy interval and congenital anomalies,” said principal investigator Dr. Innie Chen, a resident in the department of obstetrics and gynecology at the University of Alberta, Edmonton. “The observation that long intervals were associated with congenital anomalies as well as the preservation of the association for folate-independent anomalies suggests that the mechanism of the observed effect is unlikely to be mediated by folate deficiency alone.

“To date and to our knowledge, this is the most comprehensive data available on this topic. The implications of this study are broad and touch on prenatal risk assessment, prenatal counseling, and future recommendations regarding birth spacing and nutritional supplementation,” she said.

But she also cautioned that it could be problematic to apply the findings to individual women who ask when is the best time to conceive again to minimize risk.

“This is an epidemiological study. Decisions for individuals depend on a lot of things, such as where they are in their life and their career situation,” she explained. “But I think this data adds to the growing literature about the effect of interpregnancy interval and adverse perinatal outcomes, which we see again and again. Compared to 50 or 100 years ago, we have much better contraception, so I think it is within our control.”

A variety of adverse perinatal outcomes – preterm birth, small for gestational age, low birth weight, and perinatal death – have shown a J-shaped association with interpregnancy interval.

“The most-often-cited postulated mechanism for the observed effect is a folate-deficiency hypothesis, which is based on the observation that maternal serum levels are very low in the postpartum period,” Dr. Chen said.

A previous retrospective cohort study found an association between both short and long interpregnancy intervals and major congenital malformations (Contraception 2009;80:512–8). But that study did not evaluate specific types of anomalies.

Dr. Chen and her colleagues began with data from the Alberta Perinatal Health Program Database, which collects information on all hospital and midwife births, and all terminations after 20 weeks' gestation in the Northern part of the province.

They identified women who had a singleton delivery between 1999 and 2007 (the post–folate food fortification era, so that results would be applicable today) and who did not have a miscarriage between their first and second births (so that the interpregnancy interval was more reliable).

They then linked that data with data from other provincial databases to obtain more comprehensive maternal information and ascertain anomalies.

The working data set consisted of 46,559 pregnant women. The interpregnancy interval was 6–59 weeks' gestation for 90% of them.

Most of the women were 20–34 years old (83%) and para 2 (88%) at the time of the second delivery, and most of their infants had a gestational age of at least 37 weeks (93%) and a birth weight of at least 2,500 g (96%).

The rate of congenital anomalies did not vary significantly according to maternal age, maternal weight, smoking in pregnancy, or socioeconomic status, Dr. Chen reported.

For interpregnancy intervals of 59 months or less, there was a J-shaped association between the interval and the rate of congenital anomalies. The rate was lowest, at 1.9%, when the interval was 12–17 months.

It rose to a high of 2.5% when the interval was 0–5 months and 2.4% when the interval was 24–59 months. The corresponding odds ratios were 1.35 and 1.28, respectively.

The pattern was similar for folate-dependent anomalies (neural tube defects, cleft lip and palate, cardiovascular defects, urinary tract anomalies, and limb defects) and for folate-independent anomalies individually.

In addition, an interval of 0–5 months was associated with increased odds of specific anomalies, such as neural tube defects and heart defects, but not significantly so.

“We believe these results to be valid as they are consistent with and corroborate existing studies in the literature,” said Dr. Chen.

“Future directions for research include changing the databases to capture more information on all terminations and folate supplementation, combining the databases for more statistical power, and checking other postulated mechanisms for the observed effect,” she said.

VANCOUVER, B.C. – The risk of congenital anomalies for a given pregnancy varies according to the time elapsed since the last pregnancy, a retrospective population-based cohort study of more than 46,000 women has shown.

Study results, reported at the meeting, showed that the rate of congenital anomalies was lowest when the interpregnancy interval was 12–17 months and increased with both shorter and longer intervals. The pattern was similar for folate-dependent and folate-independent anomalies individually.

“A J-shaped relationship exists between interpregnancy interval and congenital anomalies,” said principal investigator Dr. Innie Chen, a resident in the department of obstetrics and gynecology at the University of Alberta, Edmonton. “The observation that long intervals were associated with congenital anomalies as well as the preservation of the association for folate-independent anomalies suggests that the mechanism of the observed effect is unlikely to be mediated by folate deficiency alone.

“To date and to our knowledge, this is the most comprehensive data available on this topic. The implications of this study are broad and touch on prenatal risk assessment, prenatal counseling, and future recommendations regarding birth spacing and nutritional supplementation,” she said.

But she also cautioned that it could be problematic to apply the findings to individual women who ask when is the best time to conceive again to minimize risk.

“This is an epidemiological study. Decisions for individuals depend on a lot of things, such as where they are in their life and their career situation,” she explained. “But I think this data adds to the growing literature about the effect of interpregnancy interval and adverse perinatal outcomes, which we see again and again. Compared to 50 or 100 years ago, we have much better contraception, so I think it is within our control.”

A variety of adverse perinatal outcomes – preterm birth, small for gestational age, low birth weight, and perinatal death – have shown a J-shaped association with interpregnancy interval.

“The most-often-cited postulated mechanism for the observed effect is a folate-deficiency hypothesis, which is based on the observation that maternal serum levels are very low in the postpartum period,” Dr. Chen said.

A previous retrospective cohort study found an association between both short and long interpregnancy intervals and major congenital malformations (Contraception 2009;80:512–8). But that study did not evaluate specific types of anomalies.

Dr. Chen and her colleagues began with data from the Alberta Perinatal Health Program Database, which collects information on all hospital and midwife births, and all terminations after 20 weeks' gestation in the Northern part of the province.

They identified women who had a singleton delivery between 1999 and 2007 (the post–folate food fortification era, so that results would be applicable today) and who did not have a miscarriage between their first and second births (so that the interpregnancy interval was more reliable).

They then linked that data with data from other provincial databases to obtain more comprehensive maternal information and ascertain anomalies.

The working data set consisted of 46,559 pregnant women. The interpregnancy interval was 6–59 weeks' gestation for 90% of them.

Most of the women were 20–34 years old (83%) and para 2 (88%) at the time of the second delivery, and most of their infants had a gestational age of at least 37 weeks (93%) and a birth weight of at least 2,500 g (96%).

The rate of congenital anomalies did not vary significantly according to maternal age, maternal weight, smoking in pregnancy, or socioeconomic status, Dr. Chen reported.

For interpregnancy intervals of 59 months or less, there was a J-shaped association between the interval and the rate of congenital anomalies. The rate was lowest, at 1.9%, when the interval was 12–17 months.

It rose to a high of 2.5% when the interval was 0–5 months and 2.4% when the interval was 24–59 months. The corresponding odds ratios were 1.35 and 1.28, respectively.

The pattern was similar for folate-dependent anomalies (neural tube defects, cleft lip and palate, cardiovascular defects, urinary tract anomalies, and limb defects) and for folate-independent anomalies individually.

In addition, an interval of 0–5 months was associated with increased odds of specific anomalies, such as neural tube defects and heart defects, but not significantly so.

“We believe these results to be valid as they are consistent with and corroborate existing studies in the literature,” said Dr. Chen.

“Future directions for research include changing the databases to capture more information on all terminations and folate supplementation, combining the databases for more statistical power, and checking other postulated mechanisms for the observed effect,” she said.

Efforts to promote vaccination of boys against human papillomavirus may be more successful if they deemphasize infection-related outcomes that make parents uncomfortable because of their sexual associations, according to a study of 158 parents of boys.

Surveyed parents were less likely to intend to vaccinate their son if they ranked anal cancer or oropharyngeal cancer as the most severe possible outcome of human papillomavirus (HPV) infection, according to Abigail C. Lees, a research assistant in the pediatrics department at the University of North Carolina, Chapel Hill.

Comments made in focus groups suggested that these cancers elicited negative emotions: stigma in the case of anal cancer because it was associated with anal sex and homosexuality, and anxiety in the case of oropharyngeal cancer because it was associated with oral sex.

“Parents seemed to dwell on the sexual transmission of HPV,” commented Ms. Lees. “HPV awareness campaigns should decrease emphasis on outcomes that elicited either stigma associated with anal cancer or increased anxiety associated with oral cancer, and instead focus on prevalence,” she recommended. “Furthermore, the parental preoccupation with the sexual transmission of HPV could be entirely avoided by vaccinating children at younger ages, when parents are less likely to associate stigmas or anxiety with their child's behavior and the vaccine.”

A quarter of the HPV-associated cancers that occurred in 2009 were in males, according to Ms. Lees.

To assess parental knowledge about male HPV outcomes and attitudes about vaccinating sons, the investigators recruited to their study parents of boys aged 11-17 years from a pediatric clinic, university listservs, craigslist, and other venues. They completed surveys asking about perceived susceptibility (at least a 40% chance) of their son experiencing HPV infection and its outcomes, and perceived severity of the outcomes. They also participated in single-sex focus groups, conducted separately in English and Spanish.

The majority of the parents, 72%, were the boy's mother. By race/ethnicity, 54% were white, 23% were black, 15% were Hispanic, and the rest were other. About a third had a high school diploma or less education. Slightly more than half were currently married. And 61% also had a daughter.

“Overall, parents believed their sons to have a low susceptibility to HPV infection and its outcomes,” Ms. Lees reported. Just 22% thought their son was susceptible to infection. And smaller proportions thought he was susceptible to genital warts (18%), oropharyngeal cancer (11%), anal cancer (9%), and penile cancer (9%). However, 82% of parents believed the consequence of HPV infection in their son would be severe; of these, 31% ranked penile cancer as the most severe possible outcome, 30% oropharyngeal cancer, 23% anal cancer, and 16% genital warts.

Eighty-three percent of parents indicated that they intended to vaccinate their sons against HPV. In a multivariate analysis, parents were more likely to intend to do so if they were older (odds ratio 1.14) and believed that the consequences of HPV infection could be severe (OR 9.94). On the other hand, they were less likely to intend to vaccinate if they were more educated (OR 0.62). And there were trends whereby they were less likely to intend to do so if they ranked anal cancer or oropharyngeal cancer as the most severe possible outcome (OR 0.25 and 0.67, respectively).

“The most striking finding from our focus groups was that parents had very limited knowledge of HPV infection in males, despite an awareness of HPV in females,” commented Ms. Lees. For example, parents were often unaware that HPV infection pertained to boys. Their comments also provided some insight into why high rankings of certain HPV-related outcomes might have been associated with lower odds of intending to vaccinate.

“Parents responded to the sexual nature of transmission, in particular, in focus groups, which revealed parental stigmatization of anal cancer by association with homosexuality among males,” she said at the annual meeting of the Society for Adolescent Health and Medicine in Seattle.

In addition, “parents expressed an anxiety associated with oral sex practices they perceived youth to be engaging in,” Ms. Lees elaborated. “Parents alluded to the frequency of oral sex among youth” and expressed “concerns that youth believe oral sex can be used to avoid infidelity, is safer than intercourse, and preserves their virginity.”

Ms. Lees reported that the investigators received grant support from Merck to conduct the study.

'The most striking finding … was that parents had a very limited knowledge of HPV infection in males.'

Source MS. LEES

Efforts to promote vaccination of boys against human papillomavirus may be more successful if they deemphasize infection-related outcomes that make parents uncomfortable because of their sexual associations, according to a study of 158 parents of boys.

Surveyed parents were less likely to intend to vaccinate their son if they ranked anal cancer or oropharyngeal cancer as the most severe possible outcome of human papillomavirus (HPV) infection, according to Abigail C. Lees, a research assistant in the pediatrics department at the University of North Carolina, Chapel Hill.

Comments made in focus groups suggested that these cancers elicited negative emotions: stigma in the case of anal cancer because it was associated with anal sex and homosexuality, and anxiety in the case of oropharyngeal cancer because it was associated with oral sex.

“Parents seemed to dwell on the sexual transmission of HPV,” commented Ms. Lees. “HPV awareness campaigns should decrease emphasis on outcomes that elicited either stigma associated with anal cancer or increased anxiety associated with oral cancer, and instead focus on prevalence,” she recommended. “Furthermore, the parental preoccupation with the sexual transmission of HPV could be entirely avoided by vaccinating children at younger ages, when parents are less likely to associate stigmas or anxiety with their child's behavior and the vaccine.”

A quarter of the HPV-associated cancers that occurred in 2009 were in males, according to Ms. Lees.

To assess parental knowledge about male HPV outcomes and attitudes about vaccinating sons, the investigators recruited to their study parents of boys aged 11-17 years from a pediatric clinic, university listservs, craigslist, and other venues. They completed surveys asking about perceived susceptibility (at least a 40% chance) of their son experiencing HPV infection and its outcomes, and perceived severity of the outcomes. They also participated in single-sex focus groups, conducted separately in English and Spanish.

The majority of the parents, 72%, were the boy's mother. By race/ethnicity, 54% were white, 23% were black, 15% were Hispanic, and the rest were other. About a third had a high school diploma or less education. Slightly more than half were currently married. And 61% also had a daughter.

“Overall, parents believed their sons to have a low susceptibility to HPV infection and its outcomes,” Ms. Lees reported. Just 22% thought their son was susceptible to infection. And smaller proportions thought he was susceptible to genital warts (18%), oropharyngeal cancer (11%), anal cancer (9%), and penile cancer (9%). However, 82% of parents believed the consequence of HPV infection in their son would be severe; of these, 31% ranked penile cancer as the most severe possible outcome, 30% oropharyngeal cancer, 23% anal cancer, and 16% genital warts.

Eighty-three percent of parents indicated that they intended to vaccinate their sons against HPV. In a multivariate analysis, parents were more likely to intend to do so if they were older (odds ratio 1.14) and believed that the consequences of HPV infection could be severe (OR 9.94). On the other hand, they were less likely to intend to vaccinate if they were more educated (OR 0.62). And there were trends whereby they were less likely to intend to do so if they ranked anal cancer or oropharyngeal cancer as the most severe possible outcome (OR 0.25 and 0.67, respectively).

“The most striking finding from our focus groups was that parents had very limited knowledge of HPV infection in males, despite an awareness of HPV in females,” commented Ms. Lees. For example, parents were often unaware that HPV infection pertained to boys. Their comments also provided some insight into why high rankings of certain HPV-related outcomes might have been associated with lower odds of intending to vaccinate.

“Parents responded to the sexual nature of transmission, in particular, in focus groups, which revealed parental stigmatization of anal cancer by association with homosexuality among males,” she said at the annual meeting of the Society for Adolescent Health and Medicine in Seattle.

In addition, “parents expressed an anxiety associated with oral sex practices they perceived youth to be engaging in,” Ms. Lees elaborated. “Parents alluded to the frequency of oral sex among youth” and expressed “concerns that youth believe oral sex can be used to avoid infidelity, is safer than intercourse, and preserves their virginity.”

Ms. Lees reported that the investigators received grant support from Merck to conduct the study.

'The most striking finding … was that parents had a very limited knowledge of HPV infection in males.'

Source MS. LEES

Efforts to promote vaccination of boys against human papillomavirus may be more successful if they deemphasize infection-related outcomes that make parents uncomfortable because of their sexual associations, according to a study of 158 parents of boys.

Surveyed parents were less likely to intend to vaccinate their son if they ranked anal cancer or oropharyngeal cancer as the most severe possible outcome of human papillomavirus (HPV) infection, according to Abigail C. Lees, a research assistant in the pediatrics department at the University of North Carolina, Chapel Hill.

Comments made in focus groups suggested that these cancers elicited negative emotions: stigma in the case of anal cancer because it was associated with anal sex and homosexuality, and anxiety in the case of oropharyngeal cancer because it was associated with oral sex.

“Parents seemed to dwell on the sexual transmission of HPV,” commented Ms. Lees. “HPV awareness campaigns should decrease emphasis on outcomes that elicited either stigma associated with anal cancer or increased anxiety associated with oral cancer, and instead focus on prevalence,” she recommended. “Furthermore, the parental preoccupation with the sexual transmission of HPV could be entirely avoided by vaccinating children at younger ages, when parents are less likely to associate stigmas or anxiety with their child's behavior and the vaccine.”

A quarter of the HPV-associated cancers that occurred in 2009 were in males, according to Ms. Lees.

To assess parental knowledge about male HPV outcomes and attitudes about vaccinating sons, the investigators recruited to their study parents of boys aged 11-17 years from a pediatric clinic, university listservs, craigslist, and other venues. They completed surveys asking about perceived susceptibility (at least a 40% chance) of their son experiencing HPV infection and its outcomes, and perceived severity of the outcomes. They also participated in single-sex focus groups, conducted separately in English and Spanish.

The majority of the parents, 72%, were the boy's mother. By race/ethnicity, 54% were white, 23% were black, 15% were Hispanic, and the rest were other. About a third had a high school diploma or less education. Slightly more than half were currently married. And 61% also had a daughter.

“Overall, parents believed their sons to have a low susceptibility to HPV infection and its outcomes,” Ms. Lees reported. Just 22% thought their son was susceptible to infection. And smaller proportions thought he was susceptible to genital warts (18%), oropharyngeal cancer (11%), anal cancer (9%), and penile cancer (9%). However, 82% of parents believed the consequence of HPV infection in their son would be severe; of these, 31% ranked penile cancer as the most severe possible outcome, 30% oropharyngeal cancer, 23% anal cancer, and 16% genital warts.

Eighty-three percent of parents indicated that they intended to vaccinate their sons against HPV. In a multivariate analysis, parents were more likely to intend to do so if they were older (odds ratio 1.14) and believed that the consequences of HPV infection could be severe (OR 9.94). On the other hand, they were less likely to intend to vaccinate if they were more educated (OR 0.62). And there were trends whereby they were less likely to intend to do so if they ranked anal cancer or oropharyngeal cancer as the most severe possible outcome (OR 0.25 and 0.67, respectively).

“The most striking finding from our focus groups was that parents had very limited knowledge of HPV infection in males, despite an awareness of HPV in females,” commented Ms. Lees. For example, parents were often unaware that HPV infection pertained to boys. Their comments also provided some insight into why high rankings of certain HPV-related outcomes might have been associated with lower odds of intending to vaccinate.

“Parents responded to the sexual nature of transmission, in particular, in focus groups, which revealed parental stigmatization of anal cancer by association with homosexuality among males,” she said at the annual meeting of the Society for Adolescent Health and Medicine in Seattle.

In addition, “parents expressed an anxiety associated with oral sex practices they perceived youth to be engaging in,” Ms. Lees elaborated. “Parents alluded to the frequency of oral sex among youth” and expressed “concerns that youth believe oral sex can be used to avoid infidelity, is safer than intercourse, and preserves their virginity.”

Ms. Lees reported that the investigators received grant support from Merck to conduct the study.

'The most striking finding … was that parents had a very limited knowledge of HPV infection in males.'

Source MS. LEES

Discussions about the human papillomavirus vaccine may be a key opportunity for providers to encourage parent-child communication about sex, suggests a cross-sectional study.

Mothers were six times more likely to have talked about sex with their adolescent daughter if her provider had discussed the human papillomavirus (HPV) vaccine with them and included topics pertaining to sexual health and development. However, there was no such association when the discussion did not include those topics.

The study's findings “suggest that … HPV discussions could be an effective way to promote communication among parents and their children,” lead investigator Annie-Laurie McRee commented at the annual meeting of the Society for Adolescent Health and Medicine in Seattle. “Heath care providers who see young adolescents can play an important role in providing information to promote communication, and we may be able to capitalize on HPV vaccine discussions to do so.”

Some providers worry that linking the vaccine with sex may actually work against its uptake, she acknowledged. But additional results suggested that mothers were more satisfied with the quality of care when their daughter's provider brought up sex and that doing so did not influence vaccine uptake. Hence, broaching the topic “might not be the detriment that many of us would be concerned about.”

Parent-child communication about sex is associated with a reduction in risky sexual behaviors during adolescence, noted Ms. McRee, a doctoral student in the department of maternal and child health at the University of North Carolina at Chapel Hill.

These conversations are most effective if they take place before the child starts having sex, but recent research suggests that parents miss that critical mark 40% of the time. “This really points to the need to find ways to promote parent communication with younger adolescents and preteens,” she said. “The HPV vaccine could offer a way to do this: Basically, because HPV is a sexually transmitted infection (STI), it may be a natural cue or a prompt for parents and health care providers to start conversations about sexual health and STI prevention.”

She further noted that the vaccine is already widely recommended, most parents intend to vaccinate their daughters, and the recommended timing of vaccination, at age 11 or 12 years, “dovetails nicely” with the optimal time to start having these important talks. Also, “since HPV vaccine is delivered in three doses over the course of 6 months, it may provide multiple opportunities to build on conversations and to promote communication that doesn't just happen early, but is continual.”

In the context of the UNC Mother-Daughter Communication Study, Ms. McRee and her coinvestigators conducted an Internet survey in December 2009, polling a nationally representative sample of mothers of girls aged 11-14 years about their communication with providers and daughters regarding HPV and sex. The 902 responding mothers were 42 years old, on average. The majority were non-Hispanic white (64%) and married or living with a partner (81%). In all, 30% had a college degree, and 20% resided in a rural area. The daughters were nearly equally divided across the ages studied, and 30% had received at least one dose of the HPV vaccine. Their mothers said 7% were possibly already sexually active.

Study results showed that 55% of mothers reported that their daughter's provider had discussed the HPV vaccine with them (usually without including sex topics). This value “is far less than we like to see, because talking about the vaccine really is a necessary precursor in most cases for daughters to receive the vaccine,” Ms. McRee said. Mothers may have forgotten that the topic was broached, or some daughters may have not yet turned 11 or 12 at their most recent visit, she said. “However, if we did look at just the 13- to 14-year-olds, still, over a third [of mothers] reported that a health care provider had never discussed HPV vaccine with them.”

Just 19% of mothers said that the provider had ever encouraged them to talk with their daughter about sex. But 31% indicated that it would be helpful if providers gave them information on how to do so, the majority of whom thought that yearly checkups or HPV vaccine visits would be a good time for providing this information. In adjusted analyses, compared with mothers who reported no provider discussion about the HPV vaccine, mothers who reported that such discussion had occurred and had included sex topics were more likely to have talked about sex with their daughter, both in the context of talking with her about the vaccine (odds ratio, 3.3) and at any time (odds ratio, 6.2).

In contrast, mothers who reported that the provider discussed the HPV vaccine with them but did not include sex topics were not significantly more likely to have talked with their daughter about sex.

“We need to find multiple ways to promote parents in talking with their children about sex,” Ms. McRee concluded. “Clearly, HPV vaccine discussions are not the only opportunity for health care providers to broach this topic or for parents to broach topics related to sexuality with their daughters. But they are a reasonably acceptable opportunity, and a potentially effective one, at an age when such conversations can be most influential.”

Ms. McRee reported she had no relevant financial conflicts. Two of her coinvestigators have received funding from Merck and GlaxoSmithKline.

Parent-child communcation about sex is associated with a reduction in risky sexual behaviors in teens.

Source MS. McREE

Discussions about the human papillomavirus vaccine may be a key opportunity for providers to encourage parent-child communication about sex, suggests a cross-sectional study.

Mothers were six times more likely to have talked about sex with their adolescent daughter if her provider had discussed the human papillomavirus (HPV) vaccine with them and included topics pertaining to sexual health and development. However, there was no such association when the discussion did not include those topics.

The study's findings “suggest that … HPV discussions could be an effective way to promote communication among parents and their children,” lead investigator Annie-Laurie McRee commented at the annual meeting of the Society for Adolescent Health and Medicine in Seattle. “Heath care providers who see young adolescents can play an important role in providing information to promote communication, and we may be able to capitalize on HPV vaccine discussions to do so.”

Some providers worry that linking the vaccine with sex may actually work against its uptake, she acknowledged. But additional results suggested that mothers were more satisfied with the quality of care when their daughter's provider brought up sex and that doing so did not influence vaccine uptake. Hence, broaching the topic “might not be the detriment that many of us would be concerned about.”

Parent-child communication about sex is associated with a reduction in risky sexual behaviors during adolescence, noted Ms. McRee, a doctoral student in the department of maternal and child health at the University of North Carolina at Chapel Hill.

These conversations are most effective if they take place before the child starts having sex, but recent research suggests that parents miss that critical mark 40% of the time. “This really points to the need to find ways to promote parent communication with younger adolescents and preteens,” she said. “The HPV vaccine could offer a way to do this: Basically, because HPV is a sexually transmitted infection (STI), it may be a natural cue or a prompt for parents and health care providers to start conversations about sexual health and STI prevention.”

She further noted that the vaccine is already widely recommended, most parents intend to vaccinate their daughters, and the recommended timing of vaccination, at age 11 or 12 years, “dovetails nicely” with the optimal time to start having these important talks. Also, “since HPV vaccine is delivered in three doses over the course of 6 months, it may provide multiple opportunities to build on conversations and to promote communication that doesn't just happen early, but is continual.”

In the context of the UNC Mother-Daughter Communication Study, Ms. McRee and her coinvestigators conducted an Internet survey in December 2009, polling a nationally representative sample of mothers of girls aged 11-14 years about their communication with providers and daughters regarding HPV and sex. The 902 responding mothers were 42 years old, on average. The majority were non-Hispanic white (64%) and married or living with a partner (81%). In all, 30% had a college degree, and 20% resided in a rural area. The daughters were nearly equally divided across the ages studied, and 30% had received at least one dose of the HPV vaccine. Their mothers said 7% were possibly already sexually active.

Study results showed that 55% of mothers reported that their daughter's provider had discussed the HPV vaccine with them (usually without including sex topics). This value “is far less than we like to see, because talking about the vaccine really is a necessary precursor in most cases for daughters to receive the vaccine,” Ms. McRee said. Mothers may have forgotten that the topic was broached, or some daughters may have not yet turned 11 or 12 at their most recent visit, she said. “However, if we did look at just the 13- to 14-year-olds, still, over a third [of mothers] reported that a health care provider had never discussed HPV vaccine with them.”

Just 19% of mothers said that the provider had ever encouraged them to talk with their daughter about sex. But 31% indicated that it would be helpful if providers gave them information on how to do so, the majority of whom thought that yearly checkups or HPV vaccine visits would be a good time for providing this information. In adjusted analyses, compared with mothers who reported no provider discussion about the HPV vaccine, mothers who reported that such discussion had occurred and had included sex topics were more likely to have talked about sex with their daughter, both in the context of talking with her about the vaccine (odds ratio, 3.3) and at any time (odds ratio, 6.2).

In contrast, mothers who reported that the provider discussed the HPV vaccine with them but did not include sex topics were not significantly more likely to have talked with their daughter about sex.

“We need to find multiple ways to promote parents in talking with their children about sex,” Ms. McRee concluded. “Clearly, HPV vaccine discussions are not the only opportunity for health care providers to broach this topic or for parents to broach topics related to sexuality with their daughters. But they are a reasonably acceptable opportunity, and a potentially effective one, at an age when such conversations can be most influential.”

Ms. McRee reported she had no relevant financial conflicts. Two of her coinvestigators have received funding from Merck and GlaxoSmithKline.

Parent-child communcation about sex is associated with a reduction in risky sexual behaviors in teens.

Source MS. McREE

Discussions about the human papillomavirus vaccine may be a key opportunity for providers to encourage parent-child communication about sex, suggests a cross-sectional study.

Mothers were six times more likely to have talked about sex with their adolescent daughter if her provider had discussed the human papillomavirus (HPV) vaccine with them and included topics pertaining to sexual health and development. However, there was no such association when the discussion did not include those topics.

The study's findings “suggest that … HPV discussions could be an effective way to promote communication among parents and their children,” lead investigator Annie-Laurie McRee commented at the annual meeting of the Society for Adolescent Health and Medicine in Seattle. “Heath care providers who see young adolescents can play an important role in providing information to promote communication, and we may be able to capitalize on HPV vaccine discussions to do so.”

Some providers worry that linking the vaccine with sex may actually work against its uptake, she acknowledged. But additional results suggested that mothers were more satisfied with the quality of care when their daughter's provider brought up sex and that doing so did not influence vaccine uptake. Hence, broaching the topic “might not be the detriment that many of us would be concerned about.”

Parent-child communication about sex is associated with a reduction in risky sexual behaviors during adolescence, noted Ms. McRee, a doctoral student in the department of maternal and child health at the University of North Carolina at Chapel Hill.

These conversations are most effective if they take place before the child starts having sex, but recent research suggests that parents miss that critical mark 40% of the time. “This really points to the need to find ways to promote parent communication with younger adolescents and preteens,” she said. “The HPV vaccine could offer a way to do this: Basically, because HPV is a sexually transmitted infection (STI), it may be a natural cue or a prompt for parents and health care providers to start conversations about sexual health and STI prevention.”

She further noted that the vaccine is already widely recommended, most parents intend to vaccinate their daughters, and the recommended timing of vaccination, at age 11 or 12 years, “dovetails nicely” with the optimal time to start having these important talks. Also, “since HPV vaccine is delivered in three doses over the course of 6 months, it may provide multiple opportunities to build on conversations and to promote communication that doesn't just happen early, but is continual.”

In the context of the UNC Mother-Daughter Communication Study, Ms. McRee and her coinvestigators conducted an Internet survey in December 2009, polling a nationally representative sample of mothers of girls aged 11-14 years about their communication with providers and daughters regarding HPV and sex. The 902 responding mothers were 42 years old, on average. The majority were non-Hispanic white (64%) and married or living with a partner (81%). In all, 30% had a college degree, and 20% resided in a rural area. The daughters were nearly equally divided across the ages studied, and 30% had received at least one dose of the HPV vaccine. Their mothers said 7% were possibly already sexually active.

Study results showed that 55% of mothers reported that their daughter's provider had discussed the HPV vaccine with them (usually without including sex topics). This value “is far less than we like to see, because talking about the vaccine really is a necessary precursor in most cases for daughters to receive the vaccine,” Ms. McRee said. Mothers may have forgotten that the topic was broached, or some daughters may have not yet turned 11 or 12 at their most recent visit, she said. “However, if we did look at just the 13- to 14-year-olds, still, over a third [of mothers] reported that a health care provider had never discussed HPV vaccine with them.”

Just 19% of mothers said that the provider had ever encouraged them to talk with their daughter about sex. But 31% indicated that it would be helpful if providers gave them information on how to do so, the majority of whom thought that yearly checkups or HPV vaccine visits would be a good time for providing this information. In adjusted analyses, compared with mothers who reported no provider discussion about the HPV vaccine, mothers who reported that such discussion had occurred and had included sex topics were more likely to have talked about sex with their daughter, both in the context of talking with her about the vaccine (odds ratio, 3.3) and at any time (odds ratio, 6.2).

In contrast, mothers who reported that the provider discussed the HPV vaccine with them but did not include sex topics were not significantly more likely to have talked with their daughter about sex.

“We need to find multiple ways to promote parents in talking with their children about sex,” Ms. McRee concluded. “Clearly, HPV vaccine discussions are not the only opportunity for health care providers to broach this topic or for parents to broach topics related to sexuality with their daughters. But they are a reasonably acceptable opportunity, and a potentially effective one, at an age when such conversations can be most influential.”

Ms. McRee reported she had no relevant financial conflicts. Two of her coinvestigators have received funding from Merck and GlaxoSmithKline.

Parent-child communcation about sex is associated with a reduction in risky sexual behaviors in teens.

Source MS. McREE