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In a randomized trial of women with early pregnancy loss, pretreatment with mifepristone before misoprostol was superior to misoprostol alone at achieving gestational sac expulsion by the time of the first follow-up visit without additional intervention.
“Women generally prefer active management; the ability to have control over the management of miscarriage may relieve some of the emotional burden that accompanies first trimester pregnancy loss,” Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, and her coauthors wrote in the New England Journal of Medicine. But misoprostol (Cytotec) alone for women with a closed cervical os can require a second dose or intervention.
The trial enrolled 300 participants. Each had an ultrasound showing a nonviable intrauterine pregnancy of 5-12 weeks’ gestation. Women with an incomplete or inevitable abortion (that is, the absence of a gestational sac, an open cervical os, or both) were excluded, as misoprostol alone is effective for management of that diagnosis.
After randomization, 149 participants received 200 mg of oral mifepristone (Mifeprex), with 800 mcg misoprostol administered approximately 24 hours later. The other 151 participants received the standard 800 mcg dose of misoprostol alone. In both groups, the misoprostol was self-administered vaginally at home by inserting four 200-mcg tablets.
Follow-up came 24 hours to 4 days after misoprostol administration. The primary outcome was a gestational sac expulsion by the time of this follow-up, and no additional surgical or medical intervention within 30 days. If the gestational sac was present at follow-up, participants chose either expectant management, surgical management, or a second misoprostol dose.
The primary outcome was achieved in 124 of 148 women (83.8%; 95% confidence interval, 76.8-89.3) in the mifepristone-pretreatment group and in 100 of 149 women (67.1%; 95% CI, 59.0-74.6) in the misoprostol-alone group for a relative risk of 1.25 (95% CI, 1.09 to 1.43). Two women were lost to follow-up and one who was declared ineligible because of a possible ectopic pregnancy.
At 30 days’ follow-up, the cumulative rate of gestational sac expulsion with up to two doses of misoprostol was 91.2% (95% CI, 85.4-95.2) in the mifepristone-pretreatment group and 75.8% (95% CI, 68.2%-82.5%) in the misoprostol-alone group. Also by 30 days’ follow-up, 13 women in the mifepristone-pretreatment group and 35 women in the misoprostol-alone group had undergone uterine aspiration (relative risk, 0.37; 95% CI, 0.21-0.68).
Serious adverse events were rare in both groups, and both groups had matching mean scores for bleeding intensity and pain.
“Pretreatment with mifepristone followed by treatment with misoprostol resulted in a significantly higher rate of complete gestational sac expulsion by approximately 2 days after treatment ... [and] a significantly lower rate of uterine aspiration than misoprostol use alone,” wrote Dr. Schreiber and her coauthors. Patient satisfaction was similar between the two groups (89.4% vs. 87.4%, respectively, described their experience overall as either “good” or “neutral”).
The trial was funded by the National Institute of Child Health and Human Development. Two coauthors reported grants from the National Institutes of Health during the study and another reported personal fees from Danco Laboratories, which markets mifepristone, outside the submitted work.
SOURCE: Schreiber CA et al. N Engl J Med. 2018;378:2161-70.
The results of this study provide strong evidence that the sequential regimen of mifepristone followed by misoprostol is safe and superior to misoprostol alone in achieving treatment success and avoiding an aspiration procedure, wrote Carolyn L. Westhoff, MD, in an editorial accompanying the article.
In addition to its greater efficacy, the mifepristone treatment is quicker, which is more desirable for patients and reduces costs, inconvenience, and patient anxiety. Some women still will need prompt access to aspiration.
The mifepristone-pretreatment regimen should be the standard of care, Dr. Westhoff writes, but access to mifepristone is limited by the FDA’s Risk Evaluation and Mitigation Strategy restriction, which requires that the oral drug be taken in the doctor’s office rather than obtained at a retail pharmacy. “Extensive clinical experience with mifepristone indicates that there is no need for such restrictions,” she wrote.
Carolyn L. Westhoff, MD, is a professor of epidemiology and population and family health at Columbia University in New York. Her remarks are adapted from an accompanying editorial (N Engl J Med. 2018;378:2232-3). She reported personal fees from Planned Parenthood, Bayer, Agile Therapeutics, Cooper Surgical, Allergan, Elsevier, and personal fees and nonfinancial support from Merck.
The results of this study provide strong evidence that the sequential regimen of mifepristone followed by misoprostol is safe and superior to misoprostol alone in achieving treatment success and avoiding an aspiration procedure, wrote Carolyn L. Westhoff, MD, in an editorial accompanying the article.
In addition to its greater efficacy, the mifepristone treatment is quicker, which is more desirable for patients and reduces costs, inconvenience, and patient anxiety. Some women still will need prompt access to aspiration.
The mifepristone-pretreatment regimen should be the standard of care, Dr. Westhoff writes, but access to mifepristone is limited by the FDA’s Risk Evaluation and Mitigation Strategy restriction, which requires that the oral drug be taken in the doctor’s office rather than obtained at a retail pharmacy. “Extensive clinical experience with mifepristone indicates that there is no need for such restrictions,” she wrote.
Carolyn L. Westhoff, MD, is a professor of epidemiology and population and family health at Columbia University in New York. Her remarks are adapted from an accompanying editorial (N Engl J Med. 2018;378:2232-3). She reported personal fees from Planned Parenthood, Bayer, Agile Therapeutics, Cooper Surgical, Allergan, Elsevier, and personal fees and nonfinancial support from Merck.
The results of this study provide strong evidence that the sequential regimen of mifepristone followed by misoprostol is safe and superior to misoprostol alone in achieving treatment success and avoiding an aspiration procedure, wrote Carolyn L. Westhoff, MD, in an editorial accompanying the article.
In addition to its greater efficacy, the mifepristone treatment is quicker, which is more desirable for patients and reduces costs, inconvenience, and patient anxiety. Some women still will need prompt access to aspiration.
The mifepristone-pretreatment regimen should be the standard of care, Dr. Westhoff writes, but access to mifepristone is limited by the FDA’s Risk Evaluation and Mitigation Strategy restriction, which requires that the oral drug be taken in the doctor’s office rather than obtained at a retail pharmacy. “Extensive clinical experience with mifepristone indicates that there is no need for such restrictions,” she wrote.
Carolyn L. Westhoff, MD, is a professor of epidemiology and population and family health at Columbia University in New York. Her remarks are adapted from an accompanying editorial (N Engl J Med. 2018;378:2232-3). She reported personal fees from Planned Parenthood, Bayer, Agile Therapeutics, Cooper Surgical, Allergan, Elsevier, and personal fees and nonfinancial support from Merck.
In a randomized trial of women with early pregnancy loss, pretreatment with mifepristone before misoprostol was superior to misoprostol alone at achieving gestational sac expulsion by the time of the first follow-up visit without additional intervention.
“Women generally prefer active management; the ability to have control over the management of miscarriage may relieve some of the emotional burden that accompanies first trimester pregnancy loss,” Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, and her coauthors wrote in the New England Journal of Medicine. But misoprostol (Cytotec) alone for women with a closed cervical os can require a second dose or intervention.
The trial enrolled 300 participants. Each had an ultrasound showing a nonviable intrauterine pregnancy of 5-12 weeks’ gestation. Women with an incomplete or inevitable abortion (that is, the absence of a gestational sac, an open cervical os, or both) were excluded, as misoprostol alone is effective for management of that diagnosis.
After randomization, 149 participants received 200 mg of oral mifepristone (Mifeprex), with 800 mcg misoprostol administered approximately 24 hours later. The other 151 participants received the standard 800 mcg dose of misoprostol alone. In both groups, the misoprostol was self-administered vaginally at home by inserting four 200-mcg tablets.
Follow-up came 24 hours to 4 days after misoprostol administration. The primary outcome was a gestational sac expulsion by the time of this follow-up, and no additional surgical or medical intervention within 30 days. If the gestational sac was present at follow-up, participants chose either expectant management, surgical management, or a second misoprostol dose.
The primary outcome was achieved in 124 of 148 women (83.8%; 95% confidence interval, 76.8-89.3) in the mifepristone-pretreatment group and in 100 of 149 women (67.1%; 95% CI, 59.0-74.6) in the misoprostol-alone group for a relative risk of 1.25 (95% CI, 1.09 to 1.43). Two women were lost to follow-up and one who was declared ineligible because of a possible ectopic pregnancy.
At 30 days’ follow-up, the cumulative rate of gestational sac expulsion with up to two doses of misoprostol was 91.2% (95% CI, 85.4-95.2) in the mifepristone-pretreatment group and 75.8% (95% CI, 68.2%-82.5%) in the misoprostol-alone group. Also by 30 days’ follow-up, 13 women in the mifepristone-pretreatment group and 35 women in the misoprostol-alone group had undergone uterine aspiration (relative risk, 0.37; 95% CI, 0.21-0.68).
Serious adverse events were rare in both groups, and both groups had matching mean scores for bleeding intensity and pain.
“Pretreatment with mifepristone followed by treatment with misoprostol resulted in a significantly higher rate of complete gestational sac expulsion by approximately 2 days after treatment ... [and] a significantly lower rate of uterine aspiration than misoprostol use alone,” wrote Dr. Schreiber and her coauthors. Patient satisfaction was similar between the two groups (89.4% vs. 87.4%, respectively, described their experience overall as either “good” or “neutral”).
The trial was funded by the National Institute of Child Health and Human Development. Two coauthors reported grants from the National Institutes of Health during the study and another reported personal fees from Danco Laboratories, which markets mifepristone, outside the submitted work.
SOURCE: Schreiber CA et al. N Engl J Med. 2018;378:2161-70.
In a randomized trial of women with early pregnancy loss, pretreatment with mifepristone before misoprostol was superior to misoprostol alone at achieving gestational sac expulsion by the time of the first follow-up visit without additional intervention.
“Women generally prefer active management; the ability to have control over the management of miscarriage may relieve some of the emotional burden that accompanies first trimester pregnancy loss,” Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, and her coauthors wrote in the New England Journal of Medicine. But misoprostol (Cytotec) alone for women with a closed cervical os can require a second dose or intervention.
The trial enrolled 300 participants. Each had an ultrasound showing a nonviable intrauterine pregnancy of 5-12 weeks’ gestation. Women with an incomplete or inevitable abortion (that is, the absence of a gestational sac, an open cervical os, or both) were excluded, as misoprostol alone is effective for management of that diagnosis.
After randomization, 149 participants received 200 mg of oral mifepristone (Mifeprex), with 800 mcg misoprostol administered approximately 24 hours later. The other 151 participants received the standard 800 mcg dose of misoprostol alone. In both groups, the misoprostol was self-administered vaginally at home by inserting four 200-mcg tablets.
Follow-up came 24 hours to 4 days after misoprostol administration. The primary outcome was a gestational sac expulsion by the time of this follow-up, and no additional surgical or medical intervention within 30 days. If the gestational sac was present at follow-up, participants chose either expectant management, surgical management, or a second misoprostol dose.
The primary outcome was achieved in 124 of 148 women (83.8%; 95% confidence interval, 76.8-89.3) in the mifepristone-pretreatment group and in 100 of 149 women (67.1%; 95% CI, 59.0-74.6) in the misoprostol-alone group for a relative risk of 1.25 (95% CI, 1.09 to 1.43). Two women were lost to follow-up and one who was declared ineligible because of a possible ectopic pregnancy.
At 30 days’ follow-up, the cumulative rate of gestational sac expulsion with up to two doses of misoprostol was 91.2% (95% CI, 85.4-95.2) in the mifepristone-pretreatment group and 75.8% (95% CI, 68.2%-82.5%) in the misoprostol-alone group. Also by 30 days’ follow-up, 13 women in the mifepristone-pretreatment group and 35 women in the misoprostol-alone group had undergone uterine aspiration (relative risk, 0.37; 95% CI, 0.21-0.68).
Serious adverse events were rare in both groups, and both groups had matching mean scores for bleeding intensity and pain.
“Pretreatment with mifepristone followed by treatment with misoprostol resulted in a significantly higher rate of complete gestational sac expulsion by approximately 2 days after treatment ... [and] a significantly lower rate of uterine aspiration than misoprostol use alone,” wrote Dr. Schreiber and her coauthors. Patient satisfaction was similar between the two groups (89.4% vs. 87.4%, respectively, described their experience overall as either “good” or “neutral”).
The trial was funded by the National Institute of Child Health and Human Development. Two coauthors reported grants from the National Institutes of Health during the study and another reported personal fees from Danco Laboratories, which markets mifepristone, outside the submitted work.
SOURCE: Schreiber CA et al. N Engl J Med. 2018;378:2161-70.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: Gestational sac expulsion was achieved in 83.8% of the mifepristone pretreatment group and in 67.1% of the misoprostol-only group.
Study details: A randomized trial of 300 women who experienced early pregnancy loss.
Disclosures: The trial was funded by the National Institute of Child Health and Human Development. Two coauthors reported grants from the National Institutes of Health during the study and another reported personal fees from Danco Laboratories, outside the submitted work.
Source: Schreiber CA et al. N Engl J Med 2018;378:2161-70.