OBG Management

CASE Patient questions need for preoperative tests

A healthy 42-year-old woman (G2P2) with abnormal uterine bleeding and a 2-cm endometrial polyp is scheduled for hysteroscopic polypectomy. After your preoperative clinic visit, the patient receives her paperwork containing information about preoperative lab work and diagnostic studies. You are asked to come into the room because she has further questions. When you arrive, the patient holds the papers out and asks, “Is all this blood work and a chest x-ray necessary? I thought I was healthy and this was a fairly simple surgery. Is there more I should be worried about?”

How would you respond?

The goal of preoperative testing is to determine which patients may be at an increased risk for experiencing an adverse perioperative event, taking into account both the inherent risks of the surgical procedure and the health of the individual patient. In the literature, the general consensus is that physicians rely too heavily on unnecessary laboratory and diagnostic testing during their preoperative assessment.¹ More than 50% of patients who underwent preoperative evaluation had at least 1 unindicated test.² These tests may result in a high frequency of abnormal findings, with less than 3% of abnormalities having clinical value or leading to a change in management.³

With health care costs accounting for almost 20% of the gross domestic product in the United States (totaling about $3.5 billion in 2017), performing unindicated preoperative testing contributes to the economic burden on health care systems, with an estimated cost of $3 to $18 million annually.^4,5 In addition, unindicated tests can increase patient anxiety and necessitate follow-up testing, possibly exposing physicians to increased liability if abnormal results are not adequately investigated.⁶

It is time to rethink our use of routine preoperative testing.

Which tests to consider—or not: Evidence-based guidance

Professional societies, including the American Board of Internal Medicine’s Choosing Wisely campaign, promote a move away from routine testing to avoid unnecessary visits and studies. In addition, the American Society of Anesthesiologists (ASA) has published recommendations to guide preoperative testing.⁷ To stratify patients’ surgical risk according to their pre-existing health conditions, the ASA created a physical status classification system (TABLE 1).⁸

In addition to individual patient characteristics, some guidelines similarly stratify surgical procedures into minor, intermediate, and major risk. The modified Johns Hopkins surgical criteria allocates surgical risk based on expected blood loss, insensible loss, and the inherent risk of a procedure separate from anesthesia (TABLE 2).⁹ Despite these guidelines, physicians responsible for preoperative evaluations continue to order laboratory and diagnostic tests that are not indicated, often over concerns of case delays or cancellations.^10,11

The following evidence-based recommendations provide guidance to gynecologists performing surgery for benign indications to determine which preoperative studies should be performed.

Serum chemistries

Basic metabolic panel (BMP). In both contemporary studies and earlier prospective studies, a preoperative BMP has a low likelihood of changing the surgical procedure or the patient’s management, especially in patients who are classified as ASA I and are undergoing minor- and intermediate-risk procedures.^12,13 Therefore, we recommend a BMP for patients in class ASA II or higher who are undergoing intermediate-risk or major surgery.¹⁴

Thyroid function. A basic tenet of preoperative evaluation is that asymptomatic patients should not be diagnosed according to lab values prior to surgical intervention. Therefore, we do not recommend routine preoperative thyroid function testing in patients without a history of thyroid disease.¹⁰ For patients with known thyroid disease, a thyroid stimulating hormone (TSH) level should be evaluated prior to major surgery, or with any changes in medication dose or symptoms, within the past year.¹⁵

Liver function tests (LFTs). Routine screening of asymptomatic individuals without risk factors for liver disease is not recommended because there is a significantly lower incidence of abnormal lab values for LFTs than for other lab tests.¹⁶ We recommend LFTs only in symptomatic patients or patients diagnosed with severe liver disease undergoing intermediate-risk or major procedures.¹⁴

Hemoglobin A1c (HbA1c). Poorly controlled diabetes is a risk factor for poor wound healing, hospital readmission, prolonged hospitalization, and adverse events following surgery.¹⁷ We recommend that HbA1c levels be drawn only for patients with known diabetes undergoing intermediate-risk or major surgery who do not have an available lab value within the past 3 months.¹⁴

Continue to: Hematologic studies...

Hematologic studies

Complete blood count (CBC). Many patients undergoing gynecologic procedures may have unreported or undiagnosed anemia secondary to abnormal uterine bleeding, which also may encompass heavy menstrual bleeding. With an abnormal CBC likely to affect preoperative management, assessment of preoperative hemoglobin levels is critical so that hemoglobin levels can be appropriately corrected before surgery. We therefore recommend obtaining a CBC for patients in class ASA II or higher who are undergoing intermediate-risk or major surgery.^10,14

Coagulation studies. Preoperative coagulation studies are unlikely to uncover previously undiagnosed inherited coagulopathies, which are generally uncommon in the general population, and they do not predict operative bleeding when ordered unnecessarily.^18,19 Therefore, we recommend preoperative coagulation studies only in patients 1) currently on anticoagulation therapy undergoing intermediate-risk or major surgery or 2) in class ASA III or higher with bleeding disorders or cirrhosis undergoing intermediate-risk or major surgery.¹⁴

Type and screen (T&S). Complicated algorithms have been proposed to determine when a preoperative T&S is necessary, but these may be impractical for busy gynecologists.²⁰ We recommend a T&S within 72 hours, or on the day, of surgery for all patients undergoing major surgery, including hysterectomy, or with an anticipated blood loss of more than 500 mL; routine crossmatching of blood is not recommended.^10,14

Urologic studies

Urine pregnancy test. Although the probability of a positive pregnancy test is likely very low, its occurrence frequently leads to the cancellation of surgery. We therefore recommend a preoperative urine pregnancy test, particularly in reproductive-aged patients with unknown pregnancy status or unreliable contraceptive habits.¹⁴ Preoperative urine pregnancy testing, even in patients who report sexual inactivity, ideally should be individualized and based on risk of fetal harm during or subsequent to surgery. Surgeries involving the uterus, or those involving possible teratogens like radiation, also should be considered when making recommendations for testing.

Urinalysis and urine culture. In asymptomatic patients undergoing general gynecologic procedures, a routine preoperative urinalysis and urine culture are of little value.¹⁸ However, among patients undergoing a urogynecologic surgical procedure, the risk of a postoperative urinary tract infection is higher than among patients undergoing a nonurogynecologic procedure.^21,22 Therefore, we typically do not recommend routine preoperative urinalysis or urine culture, but a preoperative urine culture may be beneficial in patients undergoing urogynecologic surgery.¹⁴

Continue to: Diagnostic studies...

Electrocardiography (ECG). The absolute difference in cardiovascular death is less than 1% among patients with and without ECG abnormalities undergoing a noncardiac procedure with minimal to moderate risk; therefore, routine ECG for low-risk patients should not be performed.²³ Instead, ECG should be performed in patients with known coronary artery disease or structural heart disease and in patients aged 65 years and older, since age older than 65 years is an independent predictor of significant ECG abnormalities.^24,25 We therefore recommend that the following individuals have an ECG within the last 12 months: patients aged 65 years and older, patients in class ASA II or higher with cardiovascular disease, and patients in class ASA III or higher undergoing general anesthesia. If there is a change in cardiovascular health since the most recent ECG—even if it was performed within 12 months—a repeat ECG is warranted.^10,14

Chest x-ray. Despite a high rate of abnormalities seen on routine and indicated chest x-rays, there is no significant difference in perioperative pulmonary complications among patients with a normal or abnormal chest x-ray.¹⁶ Rather than changing surgical management, these abnormal results are more likely to lead to the cancellation or postponement of a surgical procedure.⁷ We therefore recommend against routine preoperative chest x-ray.¹⁴

The bottom line

Preoperative testing serves as an additional component of surgical planning. The fact is, however, that abnormal test results are common and frequently do not correlate with surgical outcomes.²⁶ Instead, they can lead to unnecessary surgical procedure cancellations or postponements, undue anxiety in patients, increased liability among physicians, and rising health care costs.^5-7

Rather than overly relying on routine laboratory or diagnostic studies, the history and physical examination should continue to be the cornerstone for surgeons responsible for assessing surgical risk. With individualized risk assessment, specific, indicated testing rather than routine nonspecific testing can be obtained.^10,14 In short, low-risk patients undergoing noncardiac surgery are unlikely to benefit from preoperative ECG, chest x-ray, or routine laboratory testing without clinical indication. ●

CASE Patient questions need for preoperative tests

A healthy 42-year-old woman (G2P2) with abnormal uterine bleeding and a 2-cm endometrial polyp is scheduled for hysteroscopic polypectomy. After your preoperative clinic visit, the patient receives her paperwork containing information about preoperative lab work and diagnostic studies. You are asked to come into the room because she has further questions. When you arrive, the patient holds the papers out and asks, “Is all this blood work and a chest x-ray necessary? I thought I was healthy and this was a fairly simple surgery. Is there more I should be worried about?”

How would you respond?

The goal of preoperative testing is to determine which patients may be at an increased risk for experiencing an adverse perioperative event, taking into account both the inherent risks of the surgical procedure and the health of the individual patient. In the literature, the general consensus is that physicians rely too heavily on unnecessary laboratory and diagnostic testing during their preoperative assessment.¹ More than 50% of patients who underwent preoperative evaluation had at least 1 unindicated test.² These tests may result in a high frequency of abnormal findings, with less than 3% of abnormalities having clinical value or leading to a change in management.³

With health care costs accounting for almost 20% of the gross domestic product in the United States (totaling about $3.5 billion in 2017), performing unindicated preoperative testing contributes to the economic burden on health care systems, with an estimated cost of $3 to $18 million annually.^4,5 In addition, unindicated tests can increase patient anxiety and necessitate follow-up testing, possibly exposing physicians to increased liability if abnormal results are not adequately investigated.⁶

It is time to rethink our use of routine preoperative testing.

Which tests to consider—or not: Evidence-based guidance

Professional societies, including the American Board of Internal Medicine’s Choosing Wisely campaign, promote a move away from routine testing to avoid unnecessary visits and studies. In addition, the American Society of Anesthesiologists (ASA) has published recommendations to guide preoperative testing.⁷ To stratify patients’ surgical risk according to their pre-existing health conditions, the ASA created a physical status classification system (TABLE 1).⁸

In addition to individual patient characteristics, some guidelines similarly stratify surgical procedures into minor, intermediate, and major risk. The modified Johns Hopkins surgical criteria allocates surgical risk based on expected blood loss, insensible loss, and the inherent risk of a procedure separate from anesthesia (TABLE 2).⁹ Despite these guidelines, physicians responsible for preoperative evaluations continue to order laboratory and diagnostic tests that are not indicated, often over concerns of case delays or cancellations.^10,11

The following evidence-based recommendations provide guidance to gynecologists performing surgery for benign indications to determine which preoperative studies should be performed.

Serum chemistries

Basic metabolic panel (BMP). In both contemporary studies and earlier prospective studies, a preoperative BMP has a low likelihood of changing the surgical procedure or the patient’s management, especially in patients who are classified as ASA I and are undergoing minor- and intermediate-risk procedures.^12,13 Therefore, we recommend a BMP for patients in class ASA II or higher who are undergoing intermediate-risk or major surgery.¹⁴

Thyroid function. A basic tenet of preoperative evaluation is that asymptomatic patients should not be diagnosed according to lab values prior to surgical intervention. Therefore, we do not recommend routine preoperative thyroid function testing in patients without a history of thyroid disease.¹⁰ For patients with known thyroid disease, a thyroid stimulating hormone (TSH) level should be evaluated prior to major surgery, or with any changes in medication dose or symptoms, within the past year.¹⁵

Liver function tests (LFTs). Routine screening of asymptomatic individuals without risk factors for liver disease is not recommended because there is a significantly lower incidence of abnormal lab values for LFTs than for other lab tests.¹⁶ We recommend LFTs only in symptomatic patients or patients diagnosed with severe liver disease undergoing intermediate-risk or major procedures.¹⁴

Hemoglobin A1c (HbA1c). Poorly controlled diabetes is a risk factor for poor wound healing, hospital readmission, prolonged hospitalization, and adverse events following surgery.¹⁷ We recommend that HbA1c levels be drawn only for patients with known diabetes undergoing intermediate-risk or major surgery who do not have an available lab value within the past 3 months.¹⁴

Continue to: Hematologic studies...

Hematologic studies

Complete blood count (CBC). Many patients undergoing gynecologic procedures may have unreported or undiagnosed anemia secondary to abnormal uterine bleeding, which also may encompass heavy menstrual bleeding. With an abnormal CBC likely to affect preoperative management, assessment of preoperative hemoglobin levels is critical so that hemoglobin levels can be appropriately corrected before surgery. We therefore recommend obtaining a CBC for patients in class ASA II or higher who are undergoing intermediate-risk or major surgery.^10,14

Coagulation studies. Preoperative coagulation studies are unlikely to uncover previously undiagnosed inherited coagulopathies, which are generally uncommon in the general population, and they do not predict operative bleeding when ordered unnecessarily.^18,19 Therefore, we recommend preoperative coagulation studies only in patients 1) currently on anticoagulation therapy undergoing intermediate-risk or major surgery or 2) in class ASA III or higher with bleeding disorders or cirrhosis undergoing intermediate-risk or major surgery.¹⁴

Type and screen (T&S). Complicated algorithms have been proposed to determine when a preoperative T&S is necessary, but these may be impractical for busy gynecologists.²⁰ We recommend a T&S within 72 hours, or on the day, of surgery for all patients undergoing major surgery, including hysterectomy, or with an anticipated blood loss of more than 500 mL; routine crossmatching of blood is not recommended.^10,14

Urologic studies

Urine pregnancy test. Although the probability of a positive pregnancy test is likely very low, its occurrence frequently leads to the cancellation of surgery. We therefore recommend a preoperative urine pregnancy test, particularly in reproductive-aged patients with unknown pregnancy status or unreliable contraceptive habits.¹⁴ Preoperative urine pregnancy testing, even in patients who report sexual inactivity, ideally should be individualized and based on risk of fetal harm during or subsequent to surgery. Surgeries involving the uterus, or those involving possible teratogens like radiation, also should be considered when making recommendations for testing.

Urinalysis and urine culture. In asymptomatic patients undergoing general gynecologic procedures, a routine preoperative urinalysis and urine culture are of little value.¹⁸ However, among patients undergoing a urogynecologic surgical procedure, the risk of a postoperative urinary tract infection is higher than among patients undergoing a nonurogynecologic procedure.^21,22 Therefore, we typically do not recommend routine preoperative urinalysis or urine culture, but a preoperative urine culture may be beneficial in patients undergoing urogynecologic surgery.¹⁴

Continue to: Diagnostic studies...

Electrocardiography (ECG). The absolute difference in cardiovascular death is less than 1% among patients with and without ECG abnormalities undergoing a noncardiac procedure with minimal to moderate risk; therefore, routine ECG for low-risk patients should not be performed.²³ Instead, ECG should be performed in patients with known coronary artery disease or structural heart disease and in patients aged 65 years and older, since age older than 65 years is an independent predictor of significant ECG abnormalities.^24,25 We therefore recommend that the following individuals have an ECG within the last 12 months: patients aged 65 years and older, patients in class ASA II or higher with cardiovascular disease, and patients in class ASA III or higher undergoing general anesthesia. If there is a change in cardiovascular health since the most recent ECG—even if it was performed within 12 months—a repeat ECG is warranted.^10,14

Chest x-ray. Despite a high rate of abnormalities seen on routine and indicated chest x-rays, there is no significant difference in perioperative pulmonary complications among patients with a normal or abnormal chest x-ray.¹⁶ Rather than changing surgical management, these abnormal results are more likely to lead to the cancellation or postponement of a surgical procedure.⁷ We therefore recommend against routine preoperative chest x-ray.¹⁴

The bottom line

Preoperative testing serves as an additional component of surgical planning. The fact is, however, that abnormal test results are common and frequently do not correlate with surgical outcomes.²⁶ Instead, they can lead to unnecessary surgical procedure cancellations or postponements, undue anxiety in patients, increased liability among physicians, and rising health care costs.^5-7

Rather than overly relying on routine laboratory or diagnostic studies, the history and physical examination should continue to be the cornerstone for surgeons responsible for assessing surgical risk. With individualized risk assessment, specific, indicated testing rather than routine nonspecific testing can be obtained.^10,14 In short, low-risk patients undergoing noncardiac surgery are unlikely to benefit from preoperative ECG, chest x-ray, or routine laboratory testing without clinical indication. ●

CASE Patient questions need for preoperative tests

A healthy 42-year-old woman (G2P2) with abnormal uterine bleeding and a 2-cm endometrial polyp is scheduled for hysteroscopic polypectomy. After your preoperative clinic visit, the patient receives her paperwork containing information about preoperative lab work and diagnostic studies. You are asked to come into the room because she has further questions. When you arrive, the patient holds the papers out and asks, “Is all this blood work and a chest x-ray necessary? I thought I was healthy and this was a fairly simple surgery. Is there more I should be worried about?”

How would you respond?

The goal of preoperative testing is to determine which patients may be at an increased risk for experiencing an adverse perioperative event, taking into account both the inherent risks of the surgical procedure and the health of the individual patient. In the literature, the general consensus is that physicians rely too heavily on unnecessary laboratory and diagnostic testing during their preoperative assessment.¹ More than 50% of patients who underwent preoperative evaluation had at least 1 unindicated test.² These tests may result in a high frequency of abnormal findings, with less than 3% of abnormalities having clinical value or leading to a change in management.³

With health care costs accounting for almost 20% of the gross domestic product in the United States (totaling about $3.5 billion in 2017), performing unindicated preoperative testing contributes to the economic burden on health care systems, with an estimated cost of $3 to $18 million annually.^4,5 In addition, unindicated tests can increase patient anxiety and necessitate follow-up testing, possibly exposing physicians to increased liability if abnormal results are not adequately investigated.⁶

It is time to rethink our use of routine preoperative testing.

Which tests to consider—or not: Evidence-based guidance

Professional societies, including the American Board of Internal Medicine’s Choosing Wisely campaign, promote a move away from routine testing to avoid unnecessary visits and studies. In addition, the American Society of Anesthesiologists (ASA) has published recommendations to guide preoperative testing.⁷ To stratify patients’ surgical risk according to their pre-existing health conditions, the ASA created a physical status classification system (TABLE 1).⁸

In addition to individual patient characteristics, some guidelines similarly stratify surgical procedures into minor, intermediate, and major risk. The modified Johns Hopkins surgical criteria allocates surgical risk based on expected blood loss, insensible loss, and the inherent risk of a procedure separate from anesthesia (TABLE 2).⁹ Despite these guidelines, physicians responsible for preoperative evaluations continue to order laboratory and diagnostic tests that are not indicated, often over concerns of case delays or cancellations.^10,11

The following evidence-based recommendations provide guidance to gynecologists performing surgery for benign indications to determine which preoperative studies should be performed.

Serum chemistries

Basic metabolic panel (BMP). In both contemporary studies and earlier prospective studies, a preoperative BMP has a low likelihood of changing the surgical procedure or the patient’s management, especially in patients who are classified as ASA I and are undergoing minor- and intermediate-risk procedures.^12,13 Therefore, we recommend a BMP for patients in class ASA II or higher who are undergoing intermediate-risk or major surgery.¹⁴

Thyroid function. A basic tenet of preoperative evaluation is that asymptomatic patients should not be diagnosed according to lab values prior to surgical intervention. Therefore, we do not recommend routine preoperative thyroid function testing in patients without a history of thyroid disease.¹⁰ For patients with known thyroid disease, a thyroid stimulating hormone (TSH) level should be evaluated prior to major surgery, or with any changes in medication dose or symptoms, within the past year.¹⁵

Liver function tests (LFTs). Routine screening of asymptomatic individuals without risk factors for liver disease is not recommended because there is a significantly lower incidence of abnormal lab values for LFTs than for other lab tests.¹⁶ We recommend LFTs only in symptomatic patients or patients diagnosed with severe liver disease undergoing intermediate-risk or major procedures.¹⁴

Hemoglobin A1c (HbA1c). Poorly controlled diabetes is a risk factor for poor wound healing, hospital readmission, prolonged hospitalization, and adverse events following surgery.¹⁷ We recommend that HbA1c levels be drawn only for patients with known diabetes undergoing intermediate-risk or major surgery who do not have an available lab value within the past 3 months.¹⁴

Continue to: Hematologic studies...

Hematologic studies

Complete blood count (CBC). Many patients undergoing gynecologic procedures may have unreported or undiagnosed anemia secondary to abnormal uterine bleeding, which also may encompass heavy menstrual bleeding. With an abnormal CBC likely to affect preoperative management, assessment of preoperative hemoglobin levels is critical so that hemoglobin levels can be appropriately corrected before surgery. We therefore recommend obtaining a CBC for patients in class ASA II or higher who are undergoing intermediate-risk or major surgery.^10,14

Coagulation studies. Preoperative coagulation studies are unlikely to uncover previously undiagnosed inherited coagulopathies, which are generally uncommon in the general population, and they do not predict operative bleeding when ordered unnecessarily.^18,19 Therefore, we recommend preoperative coagulation studies only in patients 1) currently on anticoagulation therapy undergoing intermediate-risk or major surgery or 2) in class ASA III or higher with bleeding disorders or cirrhosis undergoing intermediate-risk or major surgery.¹⁴

Type and screen (T&S). Complicated algorithms have been proposed to determine when a preoperative T&S is necessary, but these may be impractical for busy gynecologists.²⁰ We recommend a T&S within 72 hours, or on the day, of surgery for all patients undergoing major surgery, including hysterectomy, or with an anticipated blood loss of more than 500 mL; routine crossmatching of blood is not recommended.^10,14

Urologic studies

Urine pregnancy test. Although the probability of a positive pregnancy test is likely very low, its occurrence frequently leads to the cancellation of surgery. We therefore recommend a preoperative urine pregnancy test, particularly in reproductive-aged patients with unknown pregnancy status or unreliable contraceptive habits.¹⁴ Preoperative urine pregnancy testing, even in patients who report sexual inactivity, ideally should be individualized and based on risk of fetal harm during or subsequent to surgery. Surgeries involving the uterus, or those involving possible teratogens like radiation, also should be considered when making recommendations for testing.

Urinalysis and urine culture. In asymptomatic patients undergoing general gynecologic procedures, a routine preoperative urinalysis and urine culture are of little value.¹⁸ However, among patients undergoing a urogynecologic surgical procedure, the risk of a postoperative urinary tract infection is higher than among patients undergoing a nonurogynecologic procedure.^21,22 Therefore, we typically do not recommend routine preoperative urinalysis or urine culture, but a preoperative urine culture may be beneficial in patients undergoing urogynecologic surgery.¹⁴

Continue to: Diagnostic studies...

Electrocardiography (ECG). The absolute difference in cardiovascular death is less than 1% among patients with and without ECG abnormalities undergoing a noncardiac procedure with minimal to moderate risk; therefore, routine ECG for low-risk patients should not be performed.²³ Instead, ECG should be performed in patients with known coronary artery disease or structural heart disease and in patients aged 65 years and older, since age older than 65 years is an independent predictor of significant ECG abnormalities.^24,25 We therefore recommend that the following individuals have an ECG within the last 12 months: patients aged 65 years and older, patients in class ASA II or higher with cardiovascular disease, and patients in class ASA III or higher undergoing general anesthesia. If there is a change in cardiovascular health since the most recent ECG—even if it was performed within 12 months—a repeat ECG is warranted.^10,14

Chest x-ray. Despite a high rate of abnormalities seen on routine and indicated chest x-rays, there is no significant difference in perioperative pulmonary complications among patients with a normal or abnormal chest x-ray.¹⁶ Rather than changing surgical management, these abnormal results are more likely to lead to the cancellation or postponement of a surgical procedure.⁷ We therefore recommend against routine preoperative chest x-ray.¹⁴

The bottom line

Preoperative testing serves as an additional component of surgical planning. The fact is, however, that abnormal test results are common and frequently do not correlate with surgical outcomes.²⁶ Instead, they can lead to unnecessary surgical procedure cancellations or postponements, undue anxiety in patients, increased liability among physicians, and rising health care costs.^5-7

Rather than overly relying on routine laboratory or diagnostic studies, the history and physical examination should continue to be the cornerstone for surgeons responsible for assessing surgical risk. With individualized risk assessment, specific, indicated testing rather than routine nonspecific testing can be obtained.^10,14 In short, low-risk patients undergoing noncardiac surgery are unlikely to benefit from preoperative ECG, chest x-ray, or routine laboratory testing without clinical indication. ●

In the era of long-acting reversible contraceptives (LARCs), the pill can seem obsolete. However, it is still the second most commonly used birth control method in the United States, chosen by 19% of female contraceptive users as of 2015–2017.¹ It also has noncontraceptive benefits, so it is important that obstetrician-gynecologists are well-versed in its uses. In this article, I will focus on combined oral contraceptives (COCs; TABLE 1), reviewing the major risks, benefits, and adverse effects of COCs before focusing on recommendations for particular formulations of COCs for various patient populations.

Benefits and risks

There are numerous noncontraceptive benefits of COCs, including menstrual cycle regulation; reduced risk of ovarian, endometrial, and colorectal cancer; and treatment of menorrhagia, dysmenorrhea, acne, menstrual migraine, premenstrual syndrome and premenstrual dysphoric disorder, pelvic pain due to endometriosis, and hirsutism.

Common patient concerns

In terms of adverse effects, there are more potential unwanted effects of concern to women than there are ones validated in the literature. Accepted adverse effects include nausea, breast tenderness, and decreased libido. However, one of the most common concerns voiced during contraceptive counseling is that COCs will cause weight gain. A 2014 Cochrane review identified 49 trials studying the weight gain question.² Of those, only 4 had a placebo or nonintervention group. Of these 4, there was no significant difference in weight change between the COC-receiving group and the control group. When patients bring up their concerns, it may help to remind them that women tend to gain weight over time whether or not they are taking a COC.

Another common concern is that COCs cause mood changes. A 2016 review by Schaffir and colleagues sheds some light on this topic,³ albeit limited by the paucity of prospective studies. This review identified only 1 randomized controlled trial comparing depression incidence among women initiating a COC versus a placebo. There was no difference in the incidence of depression among the groups at 3 months. Among 4 large retrospective studies of women using COCs, the agents either had no or a beneficial effect on mood. Schaffir’s review reports that there may be greater mood adverse effects with COCs among women with underlying mood disorders.

Patients may worry that COC use will permanently impair their fertility or delay return to fertility after discontinuation. Research does indicate that return of fertility after stopping COCs often takes several months (compared with immediate fertility after discontinuing a barrier method). However, there still seem to be comparable conception rates within 12 months after discontinuing COCs as there are after discontinuing other common nonhormonal or hormonal contraceptive methods. Fertility is not impacted by the duration of COC use. In addition, return to fertility seems to be comparable after discontinuation of extended cycle or continuous COCs compared with traditional-cycle COCs.⁴

COC safety

Known major risks of COCs include venous thromboembolism (VTE). The risk of VTE is about double among COC users than among nonpregnant nonusers: 3–9 per 10,000 woman-years compared with 1–5.⁵ In a study by the US Food and Drug Administration, drospirenone-containing COCs had double the risk of VTE than other COCs. However, the position of the American College of Obstetricians and Gynecologists on this increased risk of VTE with drospirenone-containing pills is that it is “possible” and “minimal.”⁵ It is important to remember that an alternative to COC use is pregnancy, in which the VTE risk is about double that among COC users, at 5–20 per 10,000 woman-years. This risk increases further in the postpartum period, to 40–65 per 10,000 woman-years.⁵

Another known major risk of COCs is arterial embolic disease, including cerebrovascular accidents and myocardial infarctions. Women at increased risk for these complications include those with hypertension, diabetes, and/or obesity and women who are aged 35 or older and smoke. Interestingly, women with migraines with aura are at increased risk for stroke but not for myocardial infarction. These women increase their risk of stroke 2- to 4-fold if they use COCs.

Continue to: Different pills for different problems...

Different pills for different problems

With so many pills on the market, it is important for clinicians to know how to choose a particular pill for a particular patient. The following discussion assumes that the patient in question desires a COC for contraception, then offers guidance on how to choose a pill with patient-specific noncontraceptive benefits (TABLE 2).

• Introvale and Seasonique, both extended-cycle formulations
• Amethyst, which is formulated without placebo pills so that it can be used continuously
• any other COC prescribed with instructions for the patient to skip placebo pills.

An extrapolated benefit to extended-cycle or continuous COCs use for heavy menstrual bleeding is addressing anemia.

For premenstrual dysphoric disorder, the only randomized controlled trials showing improvement involve drospirenone-ethinyl estradiol pills (Yaz and Yasmin).⁷ There is also evidence that extended cyclic or continuous use of these formulations is more impactful for premenstrual dysphoric disorder than a traditional cycle.⁸

Keeping migraine avoidance and prevention in mind. Various studies have looked at the impact of different COC formulations on menstrual-related symptoms. There is evidence of greater improvement in headache, bloating, and dysmenorrhea with extended cyclic or continuous use compared with traditional cyclic use.⁶

In terms of headache, let us delve into menstrual migraine in particular. Menstrual migraines occur sometime between 2 days prior to 2 days after the first day of menses and are linked to a sharp drop in estrogen levels. COCs are contraindicated in women with menstrual migraines with aura because of the increased stroke risk. For women with menstrual migraines without aura, COCs can prevent migraines. Prevention depends on minimizing fluctuations in estrogen levels; any change in estrogen level greater than 10 µg of ethinyl estradiol may trigger an estrogen-related migraine. All currently available regimens of COCs that comprise 21 days of active pills and 7 days of placebo involve a drop of more than 10 µg. Options that involve a drop of 10 µg or less include any continuous formulation, the extended formulation LoSeasonique (levonorgestrel 0.1 mg and ethinyl estradiol 20 µg for 84 days, then ethinyl estradiol 10 µg for 7 days), and Lo Loestrin (ethinyl estradiol 10 µg and norethindrone 1 mg for 24 days, then ethinyl estradiol 10 µg for 2 days, then placebo for 2 days).⁹

What’s best for acne-prone patients? All COCs should improve acne by increasing levels of sex hormone binding globulin. However, some comparative studies have shown drospirenone-containing COCs to be the most effective for acne. This finding makes sense in light of studies demonstrating antiandrogenic effects of drospirenone.¹⁰

Managing PCOS symptoms. It seems logical, by extension, that drospirenone-containing COCs would be particularly beneficial for treating hirsutism associated with polycystic ovary syndrome (PCOS). Other low‒androgenic-potential progestins, such as a third-generation progestin (norgestimate or desogestrel), might similarly be hypothesized to be advantageous. However, there is currently insufficient evidence to recommend any one COC formulation over another for the indication of PCOS.¹¹

Ovarian cysts: Can COCs be helpful? COCs are commonly prescribed by gynecologists for patients with functional ovarian cysts. It is important to note that COCs have not been found to hasten the resolution of existing cysts, so they should not be used for this purpose.¹² Studies of early COCs, which had high doses of estrogen (on the order of 50 µg), showed lower rates of cysts among users. This effect seems to be attenuated with the lower-estrogen-dose pills that are currently available, but there still appears to be benefit. Therefore, for a patient prone to cysts who desires an oral contraceptive, a COC containing estrogen 35 µg is likely to be the most beneficial of COCs currently on the market.^13,14

Lower-dosage COCs in perimenopause may be beneficial. COCs can ameliorate perimenopausal symptoms including abnormal uterine bleeding and vasomotor symptoms. Clinicians are often hesitant to prescribe COCs for perimenopausal women because of increased risk of VTE, stroke, myocardial infarction, and breast cancer with increasing age. However, age alone is not a contraindication to any contraceptive method. An extended cyclic or continuous regimen COC may be the best choice for a perimenopausal woman in order to avoid vasomotor symptoms that occur during hormone-free intervals. In addition, given the increasing risk of adverse effects like VTE with estrogen dose, a lower estrogen formulation is advisable.¹⁵

Patients with epilepsy who are taking antiepileptic drugs (AEDs) are a special population when it comes to COCs. Certain AEDs induce hepatic enzymes involved in the metabolism and protein binding of COCs, which can result in contraceptive failure. Strong inducers are carbamazepine, oxcarbazepine, perampanel, phenobarbital, phenytoin, and primidone. Weak inducers are clobazam, eslicarbazepine, felbamate, lamotrigine, rufinamide, and topiramate. Women taking any of the above AEDs are recommended to choose a different form of contraception than a COC. However, if they are limited to COCs for some reason, a preparation containing estrogen 50 µg is recommended. It is speculated that the efficacy and adverse effects of COCs with increased hormone doses, used in combination with enzyme-inducing AEDs, should be comparable to those with standard doses when not combined with AEDs; however, this speculation is unproven.¹⁶ There are few COCs on the market with estrogen doses of 50 µg, but a couple of examples are Kelnor and Ogestrel.

Additional factors have to be considered with concurrent COC use with the AED lamotrigine since COCs increase clearance of this agent. Therefore, patients taking lamotrigine who start COCs will need an increase in lamotrigine dose. To avoid fluctuations in lamotrigine serum levels, use of a continuous COC is recommended.¹⁷

Continue to: Pill types to minimize adverse effects or risks...

For women who desire to use a COC for contraception but who are at risk for a particular complication or are bothered by a particular adverse effect, ObGyns can optimize the choice of pill (TABLE 3). For example, women who have adverse effects of nausea and/or breast tenderness may benefit from reducing the estrogen dose to 20 µg or lower.¹⁸

Considering VTE

As discussed previously, VTE is a risk with all COCs, but some pills confer greater risk than others. For one, VTE risk increases with estrogen dose. In addition, VTE risk depends on the type of progestin. Drospirenone and third-generation progestins (norgestimate, gestodene, and desogestrel) confer a higher risk of VTE than first- or second-generation progestins. For example, a pill with estradiol 30 µg and either a third-generation progestin or drospirenone has a 50% to 80% higher risk of VTE compared with a pill with estradiol 30 µg and levonorgestrel.

For patients at particularly high risk for VTE, COCs are contraindicated. For patients for whom COCs are considered medically appropriate but who are at higher risk (eg, obese women), it is wise to use a pill containing a first-generation (norethindrone) or second-generation progestin (levonorgestrel) combined with the lowest dose of estrogen that has tolerable adverse effects.¹⁹

What about hypertension concerns?

Let us turn our attention briefly to hypertension and its relation to COC use. While the American College of Cardiology and the American Heart Association redefined hypertension in 2017 using a threshold of 130/80 mm Hg, the American College of Obstetricians and Gynecologists (ACOG) considers hypertension to be 140/90 mm Hg in terms of safety of using COCs. ACOG states, “women with blood pressure below 140/90 mm Hg may use any hormonal contraceptive method.”²⁰ In women with hypertension in the range of 140‒159 mm Hg systolic or 90‒99 mm Hg diastolic, COCs are category 3 according to the US Medical Eligibility Criteria for Contraceptive Use, meaning that the risks usually outweigh the benefits. For women with blood pressures of 160/110 mm Hg or greater, COCs are category 4 (contraindicated). If a woman with mild hypertension is started on a COC, a drospirenone-containing pill may be the best choice because of its diuretic effects. While other contemporary COCs have been associated with a mild increase in blood pressure, drospirenone-containing pills have not shown this association.²¹

Continue to: At issue: Break-through bleeding, mood, and weight gain...

At issue: Break-through bleeding, mood, and weight gain

For women bothered by intermenstrual bleeding, use of a COC with a third-generation progestin may be preferable to use of one with a first- or second-generation. It may be because of decreased abnormal bleeding that COCs with third-generation progestins have lower discontinuation rates.²² In addition, COCs containing estrogen 20 µg or less are associated with more intermenstrual bleeding than those with more than 20 µg estrogen.²³ Keep in mind that it is common with any COC to have intermenstrual bleeding for the first several months.

For women with pre-existing mood disorders or who report mood changes with COCs, it appears that fluctuations in hormone levels are problematic. Consistently, there is evidence that monophasic pills are preferable to multiphasic and that extended cyclic or continuous use is preferable to traditional cyclic use for mitigating mood adverse effects. There is mixed evidence on whether a low dose of ethinyl estradiol is better for mood.³

Although it is discussed above that randomized controlled trials have not shown an association between COC use and weight gain, many women remain concerned. For these women, a drospirenone-containing COC may be the best choice. Drospirenone has antimineralocorticoid activity, so it may help prevent water retention.

A brief word about multiphasic COCs. While these pills were designed to mimic physiologic hormone fluctuations and minimize hormonal adverse effects, there is insufficient evidence to compare their effects to those of monophasic pills.²⁴ Without such evidence, there is little reason to recommend a multiphasic pill to a patient over the more straightforward monophasic formulation.

Conclusion

There are more nuances to prescribing an optimal COC for a patient than may initially come to mind. It is useful to remember that any formulation of pill may be prescribed in an extended or continuous fashion, and there are benefits for such use for premenstrual dysphoric disorder, heavy menstrual bleeding, perimenopause, and menstrual symptoms. Although there are numerous brands of COCs available, a small cadre will suffice for almost all purposes. Such a “toolbox” of pills could include a pill formatted for continuous use (Seasonique), a low estrogen pill (Loestrin), a drospirenone-containing pill (Yaz), and a pill containing a third-generation progestin and a higher dose of estrogen (Sprintec). ●

In the era of long-acting reversible contraceptives (LARCs), the pill can seem obsolete. However, it is still the second most commonly used birth control method in the United States, chosen by 19% of female contraceptive users as of 2015–2017.¹ It also has noncontraceptive benefits, so it is important that obstetrician-gynecologists are well-versed in its uses. In this article, I will focus on combined oral contraceptives (COCs; TABLE 1), reviewing the major risks, benefits, and adverse effects of COCs before focusing on recommendations for particular formulations of COCs for various patient populations.

Benefits and risks

There are numerous noncontraceptive benefits of COCs, including menstrual cycle regulation; reduced risk of ovarian, endometrial, and colorectal cancer; and treatment of menorrhagia, dysmenorrhea, acne, menstrual migraine, premenstrual syndrome and premenstrual dysphoric disorder, pelvic pain due to endometriosis, and hirsutism.

Common patient concerns

In terms of adverse effects, there are more potential unwanted effects of concern to women than there are ones validated in the literature. Accepted adverse effects include nausea, breast tenderness, and decreased libido. However, one of the most common concerns voiced during contraceptive counseling is that COCs will cause weight gain. A 2014 Cochrane review identified 49 trials studying the weight gain question.² Of those, only 4 had a placebo or nonintervention group. Of these 4, there was no significant difference in weight change between the COC-receiving group and the control group. When patients bring up their concerns, it may help to remind them that women tend to gain weight over time whether or not they are taking a COC.

Another common concern is that COCs cause mood changes. A 2016 review by Schaffir and colleagues sheds some light on this topic,³ albeit limited by the paucity of prospective studies. This review identified only 1 randomized controlled trial comparing depression incidence among women initiating a COC versus a placebo. There was no difference in the incidence of depression among the groups at 3 months. Among 4 large retrospective studies of women using COCs, the agents either had no or a beneficial effect on mood. Schaffir’s review reports that there may be greater mood adverse effects with COCs among women with underlying mood disorders.

Patients may worry that COC use will permanently impair their fertility or delay return to fertility after discontinuation. Research does indicate that return of fertility after stopping COCs often takes several months (compared with immediate fertility after discontinuing a barrier method). However, there still seem to be comparable conception rates within 12 months after discontinuing COCs as there are after discontinuing other common nonhormonal or hormonal contraceptive methods. Fertility is not impacted by the duration of COC use. In addition, return to fertility seems to be comparable after discontinuation of extended cycle or continuous COCs compared with traditional-cycle COCs.⁴

COC safety

Known major risks of COCs include venous thromboembolism (VTE). The risk of VTE is about double among COC users than among nonpregnant nonusers: 3–9 per 10,000 woman-years compared with 1–5.⁵ In a study by the US Food and Drug Administration, drospirenone-containing COCs had double the risk of VTE than other COCs. However, the position of the American College of Obstetricians and Gynecologists on this increased risk of VTE with drospirenone-containing pills is that it is “possible” and “minimal.”⁵ It is important to remember that an alternative to COC use is pregnancy, in which the VTE risk is about double that among COC users, at 5–20 per 10,000 woman-years. This risk increases further in the postpartum period, to 40–65 per 10,000 woman-years.⁵

Another known major risk of COCs is arterial embolic disease, including cerebrovascular accidents and myocardial infarctions. Women at increased risk for these complications include those with hypertension, diabetes, and/or obesity and women who are aged 35 or older and smoke. Interestingly, women with migraines with aura are at increased risk for stroke but not for myocardial infarction. These women increase their risk of stroke 2- to 4-fold if they use COCs.

Continue to: Different pills for different problems...

Different pills for different problems

With so many pills on the market, it is important for clinicians to know how to choose a particular pill for a particular patient. The following discussion assumes that the patient in question desires a COC for contraception, then offers guidance on how to choose a pill with patient-specific noncontraceptive benefits (TABLE 2).

• Introvale and Seasonique, both extended-cycle formulations
• Amethyst, which is formulated without placebo pills so that it can be used continuously
• any other COC prescribed with instructions for the patient to skip placebo pills.

An extrapolated benefit to extended-cycle or continuous COCs use for heavy menstrual bleeding is addressing anemia.

For premenstrual dysphoric disorder, the only randomized controlled trials showing improvement involve drospirenone-ethinyl estradiol pills (Yaz and Yasmin).⁷ There is also evidence that extended cyclic or continuous use of these formulations is more impactful for premenstrual dysphoric disorder than a traditional cycle.⁸

Keeping migraine avoidance and prevention in mind. Various studies have looked at the impact of different COC formulations on menstrual-related symptoms. There is evidence of greater improvement in headache, bloating, and dysmenorrhea with extended cyclic or continuous use compared with traditional cyclic use.⁶

In terms of headache, let us delve into menstrual migraine in particular. Menstrual migraines occur sometime between 2 days prior to 2 days after the first day of menses and are linked to a sharp drop in estrogen levels. COCs are contraindicated in women with menstrual migraines with aura because of the increased stroke risk. For women with menstrual migraines without aura, COCs can prevent migraines. Prevention depends on minimizing fluctuations in estrogen levels; any change in estrogen level greater than 10 µg of ethinyl estradiol may trigger an estrogen-related migraine. All currently available regimens of COCs that comprise 21 days of active pills and 7 days of placebo involve a drop of more than 10 µg. Options that involve a drop of 10 µg or less include any continuous formulation, the extended formulation LoSeasonique (levonorgestrel 0.1 mg and ethinyl estradiol 20 µg for 84 days, then ethinyl estradiol 10 µg for 7 days), and Lo Loestrin (ethinyl estradiol 10 µg and norethindrone 1 mg for 24 days, then ethinyl estradiol 10 µg for 2 days, then placebo for 2 days).⁹

What’s best for acne-prone patients? All COCs should improve acne by increasing levels of sex hormone binding globulin. However, some comparative studies have shown drospirenone-containing COCs to be the most effective for acne. This finding makes sense in light of studies demonstrating antiandrogenic effects of drospirenone.¹⁰

Managing PCOS symptoms. It seems logical, by extension, that drospirenone-containing COCs would be particularly beneficial for treating hirsutism associated with polycystic ovary syndrome (PCOS). Other low‒androgenic-potential progestins, such as a third-generation progestin (norgestimate or desogestrel), might similarly be hypothesized to be advantageous. However, there is currently insufficient evidence to recommend any one COC formulation over another for the indication of PCOS.¹¹

Ovarian cysts: Can COCs be helpful? COCs are commonly prescribed by gynecologists for patients with functional ovarian cysts. It is important to note that COCs have not been found to hasten the resolution of existing cysts, so they should not be used for this purpose.¹² Studies of early COCs, which had high doses of estrogen (on the order of 50 µg), showed lower rates of cysts among users. This effect seems to be attenuated with the lower-estrogen-dose pills that are currently available, but there still appears to be benefit. Therefore, for a patient prone to cysts who desires an oral contraceptive, a COC containing estrogen 35 µg is likely to be the most beneficial of COCs currently on the market.^13,14

Lower-dosage COCs in perimenopause may be beneficial. COCs can ameliorate perimenopausal symptoms including abnormal uterine bleeding and vasomotor symptoms. Clinicians are often hesitant to prescribe COCs for perimenopausal women because of increased risk of VTE, stroke, myocardial infarction, and breast cancer with increasing age. However, age alone is not a contraindication to any contraceptive method. An extended cyclic or continuous regimen COC may be the best choice for a perimenopausal woman in order to avoid vasomotor symptoms that occur during hormone-free intervals. In addition, given the increasing risk of adverse effects like VTE with estrogen dose, a lower estrogen formulation is advisable.¹⁵

Patients with epilepsy who are taking antiepileptic drugs (AEDs) are a special population when it comes to COCs. Certain AEDs induce hepatic enzymes involved in the metabolism and protein binding of COCs, which can result in contraceptive failure. Strong inducers are carbamazepine, oxcarbazepine, perampanel, phenobarbital, phenytoin, and primidone. Weak inducers are clobazam, eslicarbazepine, felbamate, lamotrigine, rufinamide, and topiramate. Women taking any of the above AEDs are recommended to choose a different form of contraception than a COC. However, if they are limited to COCs for some reason, a preparation containing estrogen 50 µg is recommended. It is speculated that the efficacy and adverse effects of COCs with increased hormone doses, used in combination with enzyme-inducing AEDs, should be comparable to those with standard doses when not combined with AEDs; however, this speculation is unproven.¹⁶ There are few COCs on the market with estrogen doses of 50 µg, but a couple of examples are Kelnor and Ogestrel.

Additional factors have to be considered with concurrent COC use with the AED lamotrigine since COCs increase clearance of this agent. Therefore, patients taking lamotrigine who start COCs will need an increase in lamotrigine dose. To avoid fluctuations in lamotrigine serum levels, use of a continuous COC is recommended.¹⁷

Continue to: Pill types to minimize adverse effects or risks...

For women who desire to use a COC for contraception but who are at risk for a particular complication or are bothered by a particular adverse effect, ObGyns can optimize the choice of pill (TABLE 3). For example, women who have adverse effects of nausea and/or breast tenderness may benefit from reducing the estrogen dose to 20 µg or lower.¹⁸

Considering VTE

As discussed previously, VTE is a risk with all COCs, but some pills confer greater risk than others. For one, VTE risk increases with estrogen dose. In addition, VTE risk depends on the type of progestin. Drospirenone and third-generation progestins (norgestimate, gestodene, and desogestrel) confer a higher risk of VTE than first- or second-generation progestins. For example, a pill with estradiol 30 µg and either a third-generation progestin or drospirenone has a 50% to 80% higher risk of VTE compared with a pill with estradiol 30 µg and levonorgestrel.

For patients at particularly high risk for VTE, COCs are contraindicated. For patients for whom COCs are considered medically appropriate but who are at higher risk (eg, obese women), it is wise to use a pill containing a first-generation (norethindrone) or second-generation progestin (levonorgestrel) combined with the lowest dose of estrogen that has tolerable adverse effects.¹⁹

What about hypertension concerns?

Let us turn our attention briefly to hypertension and its relation to COC use. While the American College of Cardiology and the American Heart Association redefined hypertension in 2017 using a threshold of 130/80 mm Hg, the American College of Obstetricians and Gynecologists (ACOG) considers hypertension to be 140/90 mm Hg in terms of safety of using COCs. ACOG states, “women with blood pressure below 140/90 mm Hg may use any hormonal contraceptive method.”²⁰ In women with hypertension in the range of 140‒159 mm Hg systolic or 90‒99 mm Hg diastolic, COCs are category 3 according to the US Medical Eligibility Criteria for Contraceptive Use, meaning that the risks usually outweigh the benefits. For women with blood pressures of 160/110 mm Hg or greater, COCs are category 4 (contraindicated). If a woman with mild hypertension is started on a COC, a drospirenone-containing pill may be the best choice because of its diuretic effects. While other contemporary COCs have been associated with a mild increase in blood pressure, drospirenone-containing pills have not shown this association.²¹

Continue to: At issue: Break-through bleeding, mood, and weight gain...

At issue: Break-through bleeding, mood, and weight gain

For women bothered by intermenstrual bleeding, use of a COC with a third-generation progestin may be preferable to use of one with a first- or second-generation. It may be because of decreased abnormal bleeding that COCs with third-generation progestins have lower discontinuation rates.²² In addition, COCs containing estrogen 20 µg or less are associated with more intermenstrual bleeding than those with more than 20 µg estrogen.²³ Keep in mind that it is common with any COC to have intermenstrual bleeding for the first several months.

For women with pre-existing mood disorders or who report mood changes with COCs, it appears that fluctuations in hormone levels are problematic. Consistently, there is evidence that monophasic pills are preferable to multiphasic and that extended cyclic or continuous use is preferable to traditional cyclic use for mitigating mood adverse effects. There is mixed evidence on whether a low dose of ethinyl estradiol is better for mood.³

Although it is discussed above that randomized controlled trials have not shown an association between COC use and weight gain, many women remain concerned. For these women, a drospirenone-containing COC may be the best choice. Drospirenone has antimineralocorticoid activity, so it may help prevent water retention.

A brief word about multiphasic COCs. While these pills were designed to mimic physiologic hormone fluctuations and minimize hormonal adverse effects, there is insufficient evidence to compare their effects to those of monophasic pills.²⁴ Without such evidence, there is little reason to recommend a multiphasic pill to a patient over the more straightforward monophasic formulation.

Conclusion

There are more nuances to prescribing an optimal COC for a patient than may initially come to mind. It is useful to remember that any formulation of pill may be prescribed in an extended or continuous fashion, and there are benefits for such use for premenstrual dysphoric disorder, heavy menstrual bleeding, perimenopause, and menstrual symptoms. Although there are numerous brands of COCs available, a small cadre will suffice for almost all purposes. Such a “toolbox” of pills could include a pill formatted for continuous use (Seasonique), a low estrogen pill (Loestrin), a drospirenone-containing pill (Yaz), and a pill containing a third-generation progestin and a higher dose of estrogen (Sprintec). ●

In the era of long-acting reversible contraceptives (LARCs), the pill can seem obsolete. However, it is still the second most commonly used birth control method in the United States, chosen by 19% of female contraceptive users as of 2015–2017.¹ It also has noncontraceptive benefits, so it is important that obstetrician-gynecologists are well-versed in its uses. In this article, I will focus on combined oral contraceptives (COCs; TABLE 1), reviewing the major risks, benefits, and adverse effects of COCs before focusing on recommendations for particular formulations of COCs for various patient populations.

Benefits and risks

There are numerous noncontraceptive benefits of COCs, including menstrual cycle regulation; reduced risk of ovarian, endometrial, and colorectal cancer; and treatment of menorrhagia, dysmenorrhea, acne, menstrual migraine, premenstrual syndrome and premenstrual dysphoric disorder, pelvic pain due to endometriosis, and hirsutism.

Common patient concerns

In terms of adverse effects, there are more potential unwanted effects of concern to women than there are ones validated in the literature. Accepted adverse effects include nausea, breast tenderness, and decreased libido. However, one of the most common concerns voiced during contraceptive counseling is that COCs will cause weight gain. A 2014 Cochrane review identified 49 trials studying the weight gain question.² Of those, only 4 had a placebo or nonintervention group. Of these 4, there was no significant difference in weight change between the COC-receiving group and the control group. When patients bring up their concerns, it may help to remind them that women tend to gain weight over time whether or not they are taking a COC.

Another common concern is that COCs cause mood changes. A 2016 review by Schaffir and colleagues sheds some light on this topic,³ albeit limited by the paucity of prospective studies. This review identified only 1 randomized controlled trial comparing depression incidence among women initiating a COC versus a placebo. There was no difference in the incidence of depression among the groups at 3 months. Among 4 large retrospective studies of women using COCs, the agents either had no or a beneficial effect on mood. Schaffir’s review reports that there may be greater mood adverse effects with COCs among women with underlying mood disorders.

Patients may worry that COC use will permanently impair their fertility or delay return to fertility after discontinuation. Research does indicate that return of fertility after stopping COCs often takes several months (compared with immediate fertility after discontinuing a barrier method). However, there still seem to be comparable conception rates within 12 months after discontinuing COCs as there are after discontinuing other common nonhormonal or hormonal contraceptive methods. Fertility is not impacted by the duration of COC use. In addition, return to fertility seems to be comparable after discontinuation of extended cycle or continuous COCs compared with traditional-cycle COCs.⁴

COC safety

Known major risks of COCs include venous thromboembolism (VTE). The risk of VTE is about double among COC users than among nonpregnant nonusers: 3–9 per 10,000 woman-years compared with 1–5.⁵ In a study by the US Food and Drug Administration, drospirenone-containing COCs had double the risk of VTE than other COCs. However, the position of the American College of Obstetricians and Gynecologists on this increased risk of VTE with drospirenone-containing pills is that it is “possible” and “minimal.”⁵ It is important to remember that an alternative to COC use is pregnancy, in which the VTE risk is about double that among COC users, at 5–20 per 10,000 woman-years. This risk increases further in the postpartum period, to 40–65 per 10,000 woman-years.⁵

Another known major risk of COCs is arterial embolic disease, including cerebrovascular accidents and myocardial infarctions. Women at increased risk for these complications include those with hypertension, diabetes, and/or obesity and women who are aged 35 or older and smoke. Interestingly, women with migraines with aura are at increased risk for stroke but not for myocardial infarction. These women increase their risk of stroke 2- to 4-fold if they use COCs.

Continue to: Different pills for different problems...

Different pills for different problems

With so many pills on the market, it is important for clinicians to know how to choose a particular pill for a particular patient. The following discussion assumes that the patient in question desires a COC for contraception, then offers guidance on how to choose a pill with patient-specific noncontraceptive benefits (TABLE 2).

• Introvale and Seasonique, both extended-cycle formulations
• Amethyst, which is formulated without placebo pills so that it can be used continuously
• any other COC prescribed with instructions for the patient to skip placebo pills.

An extrapolated benefit to extended-cycle or continuous COCs use for heavy menstrual bleeding is addressing anemia.

For premenstrual dysphoric disorder, the only randomized controlled trials showing improvement involve drospirenone-ethinyl estradiol pills (Yaz and Yasmin).⁷ There is also evidence that extended cyclic or continuous use of these formulations is more impactful for premenstrual dysphoric disorder than a traditional cycle.⁸

Keeping migraine avoidance and prevention in mind. Various studies have looked at the impact of different COC formulations on menstrual-related symptoms. There is evidence of greater improvement in headache, bloating, and dysmenorrhea with extended cyclic or continuous use compared with traditional cyclic use.⁶

In terms of headache, let us delve into menstrual migraine in particular. Menstrual migraines occur sometime between 2 days prior to 2 days after the first day of menses and are linked to a sharp drop in estrogen levels. COCs are contraindicated in women with menstrual migraines with aura because of the increased stroke risk. For women with menstrual migraines without aura, COCs can prevent migraines. Prevention depends on minimizing fluctuations in estrogen levels; any change in estrogen level greater than 10 µg of ethinyl estradiol may trigger an estrogen-related migraine. All currently available regimens of COCs that comprise 21 days of active pills and 7 days of placebo involve a drop of more than 10 µg. Options that involve a drop of 10 µg or less include any continuous formulation, the extended formulation LoSeasonique (levonorgestrel 0.1 mg and ethinyl estradiol 20 µg for 84 days, then ethinyl estradiol 10 µg for 7 days), and Lo Loestrin (ethinyl estradiol 10 µg and norethindrone 1 mg for 24 days, then ethinyl estradiol 10 µg for 2 days, then placebo for 2 days).⁹

What’s best for acne-prone patients? All COCs should improve acne by increasing levels of sex hormone binding globulin. However, some comparative studies have shown drospirenone-containing COCs to be the most effective for acne. This finding makes sense in light of studies demonstrating antiandrogenic effects of drospirenone.¹⁰

Managing PCOS symptoms. It seems logical, by extension, that drospirenone-containing COCs would be particularly beneficial for treating hirsutism associated with polycystic ovary syndrome (PCOS). Other low‒androgenic-potential progestins, such as a third-generation progestin (norgestimate or desogestrel), might similarly be hypothesized to be advantageous. However, there is currently insufficient evidence to recommend any one COC formulation over another for the indication of PCOS.¹¹

Ovarian cysts: Can COCs be helpful? COCs are commonly prescribed by gynecologists for patients with functional ovarian cysts. It is important to note that COCs have not been found to hasten the resolution of existing cysts, so they should not be used for this purpose.¹² Studies of early COCs, which had high doses of estrogen (on the order of 50 µg), showed lower rates of cysts among users. This effect seems to be attenuated with the lower-estrogen-dose pills that are currently available, but there still appears to be benefit. Therefore, for a patient prone to cysts who desires an oral contraceptive, a COC containing estrogen 35 µg is likely to be the most beneficial of COCs currently on the market.^13,14

Lower-dosage COCs in perimenopause may be beneficial. COCs can ameliorate perimenopausal symptoms including abnormal uterine bleeding and vasomotor symptoms. Clinicians are often hesitant to prescribe COCs for perimenopausal women because of increased risk of VTE, stroke, myocardial infarction, and breast cancer with increasing age. However, age alone is not a contraindication to any contraceptive method. An extended cyclic or continuous regimen COC may be the best choice for a perimenopausal woman in order to avoid vasomotor symptoms that occur during hormone-free intervals. In addition, given the increasing risk of adverse effects like VTE with estrogen dose, a lower estrogen formulation is advisable.¹⁵

Patients with epilepsy who are taking antiepileptic drugs (AEDs) are a special population when it comes to COCs. Certain AEDs induce hepatic enzymes involved in the metabolism and protein binding of COCs, which can result in contraceptive failure. Strong inducers are carbamazepine, oxcarbazepine, perampanel, phenobarbital, phenytoin, and primidone. Weak inducers are clobazam, eslicarbazepine, felbamate, lamotrigine, rufinamide, and topiramate. Women taking any of the above AEDs are recommended to choose a different form of contraception than a COC. However, if they are limited to COCs for some reason, a preparation containing estrogen 50 µg is recommended. It is speculated that the efficacy and adverse effects of COCs with increased hormone doses, used in combination with enzyme-inducing AEDs, should be comparable to those with standard doses when not combined with AEDs; however, this speculation is unproven.¹⁶ There are few COCs on the market with estrogen doses of 50 µg, but a couple of examples are Kelnor and Ogestrel.

Additional factors have to be considered with concurrent COC use with the AED lamotrigine since COCs increase clearance of this agent. Therefore, patients taking lamotrigine who start COCs will need an increase in lamotrigine dose. To avoid fluctuations in lamotrigine serum levels, use of a continuous COC is recommended.¹⁷

Continue to: Pill types to minimize adverse effects or risks...

For women who desire to use a COC for contraception but who are at risk for a particular complication or are bothered by a particular adverse effect, ObGyns can optimize the choice of pill (TABLE 3). For example, women who have adverse effects of nausea and/or breast tenderness may benefit from reducing the estrogen dose to 20 µg or lower.¹⁸

Considering VTE

As discussed previously, VTE is a risk with all COCs, but some pills confer greater risk than others. For one, VTE risk increases with estrogen dose. In addition, VTE risk depends on the type of progestin. Drospirenone and third-generation progestins (norgestimate, gestodene, and desogestrel) confer a higher risk of VTE than first- or second-generation progestins. For example, a pill with estradiol 30 µg and either a third-generation progestin or drospirenone has a 50% to 80% higher risk of VTE compared with a pill with estradiol 30 µg and levonorgestrel.

For patients at particularly high risk for VTE, COCs are contraindicated. For patients for whom COCs are considered medically appropriate but who are at higher risk (eg, obese women), it is wise to use a pill containing a first-generation (norethindrone) or second-generation progestin (levonorgestrel) combined with the lowest dose of estrogen that has tolerable adverse effects.¹⁹

What about hypertension concerns?

Let us turn our attention briefly to hypertension and its relation to COC use. While the American College of Cardiology and the American Heart Association redefined hypertension in 2017 using a threshold of 130/80 mm Hg, the American College of Obstetricians and Gynecologists (ACOG) considers hypertension to be 140/90 mm Hg in terms of safety of using COCs. ACOG states, “women with blood pressure below 140/90 mm Hg may use any hormonal contraceptive method.”²⁰ In women with hypertension in the range of 140‒159 mm Hg systolic or 90‒99 mm Hg diastolic, COCs are category 3 according to the US Medical Eligibility Criteria for Contraceptive Use, meaning that the risks usually outweigh the benefits. For women with blood pressures of 160/110 mm Hg or greater, COCs are category 4 (contraindicated). If a woman with mild hypertension is started on a COC, a drospirenone-containing pill may be the best choice because of its diuretic effects. While other contemporary COCs have been associated with a mild increase in blood pressure, drospirenone-containing pills have not shown this association.²¹

Continue to: At issue: Break-through bleeding, mood, and weight gain...

At issue: Break-through bleeding, mood, and weight gain

For women bothered by intermenstrual bleeding, use of a COC with a third-generation progestin may be preferable to use of one with a first- or second-generation. It may be because of decreased abnormal bleeding that COCs with third-generation progestins have lower discontinuation rates.²² In addition, COCs containing estrogen 20 µg or less are associated with more intermenstrual bleeding than those with more than 20 µg estrogen.²³ Keep in mind that it is common with any COC to have intermenstrual bleeding for the first several months.

For women with pre-existing mood disorders or who report mood changes with COCs, it appears that fluctuations in hormone levels are problematic. Consistently, there is evidence that monophasic pills are preferable to multiphasic and that extended cyclic or continuous use is preferable to traditional cyclic use for mitigating mood adverse effects. There is mixed evidence on whether a low dose of ethinyl estradiol is better for mood.³

Although it is discussed above that randomized controlled trials have not shown an association between COC use and weight gain, many women remain concerned. For these women, a drospirenone-containing COC may be the best choice. Drospirenone has antimineralocorticoid activity, so it may help prevent water retention.

A brief word about multiphasic COCs. While these pills were designed to mimic physiologic hormone fluctuations and minimize hormonal adverse effects, there is insufficient evidence to compare their effects to those of monophasic pills.²⁴ Without such evidence, there is little reason to recommend a multiphasic pill to a patient over the more straightforward monophasic formulation.

Conclusion

There are more nuances to prescribing an optimal COC for a patient than may initially come to mind. It is useful to remember that any formulation of pill may be prescribed in an extended or continuous fashion, and there are benefits for such use for premenstrual dysphoric disorder, heavy menstrual bleeding, perimenopause, and menstrual symptoms. Although there are numerous brands of COCs available, a small cadre will suffice for almost all purposes. Such a “toolbox” of pills could include a pill formatted for continuous use (Seasonique), a low estrogen pill (Loestrin), a drospirenone-containing pill (Yaz), and a pill containing a third-generation progestin and a higher dose of estrogen (Sprintec). ●

Endometrial cancer is the most common gynecologic ma­lignancy, with approximately 59,000 cases diagnosed annually,¹ and a lifetime risk of approximately 3.1% in the United States.² Type I endometrial cancer includes tumors with endometrioid histology that are grade 1 or 2. Type II endometrial cancer includes tumors that have grade 3 endometrioid or nonendometrioid histology, including serous, clear cell, mucinous, squamous transitional cell, mesonephric, and undifferentiated tumors.³ Type I endometrial cancer is hormone sensitive, generally stimulated by estrogen and suppressed by progestins.

Endometrial cancer is diagnosed at a mean age of 63 years,⁴ and only 15% of cases occur before age 50.⁵ Women with an elevated body mass index (BMI) have a markedly increased risk of both Types I and II endometrial cancer (TABLE).⁶ Hence, endometrial cancer is highly prevalent in obese postmenopausal women. For these women health interventions that may reduce the risk of developing endometrial cancer include dieting, physical activity, bariatric surgery, and progestin therapy.

Educating patients is a priority

Many women do not know that postmenopausal bleeding is a sign of endometrial cancer. All postmenopausal women should be advised that if they develop vaginal bleeding they need to be evaluated by a clinician.⁷ Women who are knowledgeable about the link between postmenopausal vaginal bleeding and endometrial cancer can be encouraged to share this information with their postmenopausal friends in order to reach more people with this important information. All obese postmenopausal women should be advised that weight loss and increased physical activity can reduce the risk of developing endometrial cancer.

How weight loss and physical activity affect risk

Intentional weight loss has been reported to reduce the risk of endometrial cancer in postmenopausal women. As part of the Women’s Health Initiative observational study, 36,794 postmenopausal women aged 50 to 79 years with a uterus had their body weight and height measured at entry into the study and after 3 years of follow-up.⁸ During the 11 years following study entry, there were 566 incident cases of endometrial cancer. Compared with women who had a stable weight, intentional weight loss of ≥5% was associated with a 40% reduction in the risk of endometrial cancer (hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.42–0.86). Compared with women who had a stable weight, women who had weight gain ≥10% had an increased risk of endometrial cancer (HR, 1.26; 95% CI, 1.00–1.57).

High levels of physical activity may be associated with a decreased risk of endometrial cancer. In one study, compared with a sedentary lifestyle, higher levels of physical activity were reported to be associated with a decreased risk of endometrial cancer.⁹

Continue to: How bariatric surgery affects risk...

Many cancers are associated with obesity, including endometrial, breast, colon, pancreas, gallbladder, and renal. Obesity is associated with increased conversion of androgens to estrogens in fat tissue, stimulating excessive endometrial proliferation and increasing the risk of endometrial hyperplasia and cancer. Bariatric surgery reliably causes sustained weight reduction. Multiple studies have reported that bariatric surgery reduces the risk of endometrial cancer.

Schauer and colleagues used data from the Kaiser Permanente health system to identify 22,198 obese people who had undergone bariatric surgery and 66,427 matched controls who were obese but did not have surgery.¹⁰ The study population was 81% female, with a mean age of 45 years and a mean BMI of 45 kg/m². After an average 3.5 years of follow-up there were 2,542 incident cases of cancer, including 322 cases of endometrial cancer. Compared with conventional weight loss treatment, bariatric surgery reduced the risk of endometrial cancer by 50% (HR, 0.50; 95% CI, 0.37–0.67; P<.001).¹⁰ In addition, bariatric surgery reduced the risk of colon and pancreatic cancer by 41% and 54%, respectively.¹⁰

In the Swedish Obese Subjects (SOS) study, 1,420 women who underwent bariatric surgery and 1,447 matched controls who received conventional obesity treatment were followed for 18 years.¹¹ At study entry, the mean age of the women was approximately 48 years, and the mean BMI was approximately 42 kg/m². In follow-up there were 76 incident cases of endometrial cancer. Compared with women receiving conventional obesity treatment, women who had bariatric surgery had a non–statistically significant 49% decrease in the risk of developing endometrial cancer (HR, 0.51; 95% CI, 0.24–1.10)

In a systematic review of 5 additional studies (not including publications 10 or 11) of the impact of bariatric surgery on the risk of developing endometrial cancer, the surgery was associated with a 68% risk reduction (odds ratio [OR], 0.32; 95% CI, 0.16–0.63) compared with matched obese women that did not have surgery.¹²

Although there are no randomized prospective studies showing that bariatric surgery reduces the risk of endometrial cancer, the weight of the observation evidence is strong. In addition, bariatric surgery was reported to reduce all-cause mortality in the SOS study.¹³ Hence, for obese postmenopausal women, if lifestyle changes do not result in sustained weight loss, bariatric surgery may be an optimal approach to improving health outcomes.

Continue to: Progestin treatment and endometrial cancer risk...

Estrogen stimulates endometrial cell proliferation. Hence, unopposed chronic exposure to estrogen is a major risk factor for developing endometrial hyperplasia and cancer. Progestins block the proliferative effect of estrogen and cause cell differentiation, resulting in stromal decidualization. Progestins also reduce the concentration of estrogen and progesterone receptors and increase the activity of enzymes that convert estradiol to estrone, blocking estrogen-induced endometrial proliferation.¹⁴

In women with endometrial hyperplasia, progestins have been shown to be effective in resolving the hyperplasia in approximately 80% of cases. Both oral progestins and the 52-mg levonorgestrel-containing intrauterine device (LNG-IUD) have been reported to be effective in the treatment of endometrial hyperplasia. In a Cochrane systematic review and meta-analysis, the 52-mg LNG-IUD was reported to be somewhat more effective in resolving endometrial hyperplasia than cyclic oral progestins (89% vs 72%, respectively).¹⁵

Other studies have also reported that the 52 mg LNG-IUD was more effective than oral progestin therapy for women with complex atypical endometrial hyperplasia.¹⁶ There are no large randomized clinical trials of progestin therapy on prevention for future development of endometrial cancer in obese postmenopausal women who have a normal endometrial histology. However, for an obese perimenopausal woman, insertion of a 52-mg LNG-IUD may help to minimize excessive uterine bleeding during the menopause transition and reduce the risk of developing endometrial hyperplasia during the early postmenopause.

We can help our patients reduce their risk of endometrial cancer

Obese postmenopausal women are at increased risk for developing endometrial cancer. Gynecologists play an important role in the prevention and early detection of endometrial cancer. We can make a difference and improve the health of our obese peri- and postmenopausal women by recommending interventions that reduce the risk of endometrial cancer, thereby improving the health of our patients. ●

Endometrial cancer is the most common gynecologic ma­lignancy, with approximately 59,000 cases diagnosed annually,¹ and a lifetime risk of approximately 3.1% in the United States.² Type I endometrial cancer includes tumors with endometrioid histology that are grade 1 or 2. Type II endometrial cancer includes tumors that have grade 3 endometrioid or nonendometrioid histology, including serous, clear cell, mucinous, squamous transitional cell, mesonephric, and undifferentiated tumors.³ Type I endometrial cancer is hormone sensitive, generally stimulated by estrogen and suppressed by progestins.

Endometrial cancer is diagnosed at a mean age of 63 years,⁴ and only 15% of cases occur before age 50.⁵ Women with an elevated body mass index (BMI) have a markedly increased risk of both Types I and II endometrial cancer (TABLE).⁶ Hence, endometrial cancer is highly prevalent in obese postmenopausal women. For these women health interventions that may reduce the risk of developing endometrial cancer include dieting, physical activity, bariatric surgery, and progestin therapy.

Educating patients is a priority

Many women do not know that postmenopausal bleeding is a sign of endometrial cancer. All postmenopausal women should be advised that if they develop vaginal bleeding they need to be evaluated by a clinician.⁷ Women who are knowledgeable about the link between postmenopausal vaginal bleeding and endometrial cancer can be encouraged to share this information with their postmenopausal friends in order to reach more people with this important information. All obese postmenopausal women should be advised that weight loss and increased physical activity can reduce the risk of developing endometrial cancer.

How weight loss and physical activity affect risk

Intentional weight loss has been reported to reduce the risk of endometrial cancer in postmenopausal women. As part of the Women’s Health Initiative observational study, 36,794 postmenopausal women aged 50 to 79 years with a uterus had their body weight and height measured at entry into the study and after 3 years of follow-up.⁸ During the 11 years following study entry, there were 566 incident cases of endometrial cancer. Compared with women who had a stable weight, intentional weight loss of ≥5% was associated with a 40% reduction in the risk of endometrial cancer (hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.42–0.86). Compared with women who had a stable weight, women who had weight gain ≥10% had an increased risk of endometrial cancer (HR, 1.26; 95% CI, 1.00–1.57).

High levels of physical activity may be associated with a decreased risk of endometrial cancer. In one study, compared with a sedentary lifestyle, higher levels of physical activity were reported to be associated with a decreased risk of endometrial cancer.⁹

Continue to: How bariatric surgery affects risk...

Many cancers are associated with obesity, including endometrial, breast, colon, pancreas, gallbladder, and renal. Obesity is associated with increased conversion of androgens to estrogens in fat tissue, stimulating excessive endometrial proliferation and increasing the risk of endometrial hyperplasia and cancer. Bariatric surgery reliably causes sustained weight reduction. Multiple studies have reported that bariatric surgery reduces the risk of endometrial cancer.

Schauer and colleagues used data from the Kaiser Permanente health system to identify 22,198 obese people who had undergone bariatric surgery and 66,427 matched controls who were obese but did not have surgery.¹⁰ The study population was 81% female, with a mean age of 45 years and a mean BMI of 45 kg/m². After an average 3.5 years of follow-up there were 2,542 incident cases of cancer, including 322 cases of endometrial cancer. Compared with conventional weight loss treatment, bariatric surgery reduced the risk of endometrial cancer by 50% (HR, 0.50; 95% CI, 0.37–0.67; P<.001).¹⁰ In addition, bariatric surgery reduced the risk of colon and pancreatic cancer by 41% and 54%, respectively.¹⁰

In the Swedish Obese Subjects (SOS) study, 1,420 women who underwent bariatric surgery and 1,447 matched controls who received conventional obesity treatment were followed for 18 years.¹¹ At study entry, the mean age of the women was approximately 48 years, and the mean BMI was approximately 42 kg/m². In follow-up there were 76 incident cases of endometrial cancer. Compared with women receiving conventional obesity treatment, women who had bariatric surgery had a non–statistically significant 49% decrease in the risk of developing endometrial cancer (HR, 0.51; 95% CI, 0.24–1.10)

In a systematic review of 5 additional studies (not including publications 10 or 11) of the impact of bariatric surgery on the risk of developing endometrial cancer, the surgery was associated with a 68% risk reduction (odds ratio [OR], 0.32; 95% CI, 0.16–0.63) compared with matched obese women that did not have surgery.¹²

Although there are no randomized prospective studies showing that bariatric surgery reduces the risk of endometrial cancer, the weight of the observation evidence is strong. In addition, bariatric surgery was reported to reduce all-cause mortality in the SOS study.¹³ Hence, for obese postmenopausal women, if lifestyle changes do not result in sustained weight loss, bariatric surgery may be an optimal approach to improving health outcomes.

Continue to: Progestin treatment and endometrial cancer risk...

Estrogen stimulates endometrial cell proliferation. Hence, unopposed chronic exposure to estrogen is a major risk factor for developing endometrial hyperplasia and cancer. Progestins block the proliferative effect of estrogen and cause cell differentiation, resulting in stromal decidualization. Progestins also reduce the concentration of estrogen and progesterone receptors and increase the activity of enzymes that convert estradiol to estrone, blocking estrogen-induced endometrial proliferation.¹⁴

In women with endometrial hyperplasia, progestins have been shown to be effective in resolving the hyperplasia in approximately 80% of cases. Both oral progestins and the 52-mg levonorgestrel-containing intrauterine device (LNG-IUD) have been reported to be effective in the treatment of endometrial hyperplasia. In a Cochrane systematic review and meta-analysis, the 52-mg LNG-IUD was reported to be somewhat more effective in resolving endometrial hyperplasia than cyclic oral progestins (89% vs 72%, respectively).¹⁵

Other studies have also reported that the 52 mg LNG-IUD was more effective than oral progestin therapy for women with complex atypical endometrial hyperplasia.¹⁶ There are no large randomized clinical trials of progestin therapy on prevention for future development of endometrial cancer in obese postmenopausal women who have a normal endometrial histology. However, for an obese perimenopausal woman, insertion of a 52-mg LNG-IUD may help to minimize excessive uterine bleeding during the menopause transition and reduce the risk of developing endometrial hyperplasia during the early postmenopause.

We can help our patients reduce their risk of endometrial cancer

Obese postmenopausal women are at increased risk for developing endometrial cancer. Gynecologists play an important role in the prevention and early detection of endometrial cancer. We can make a difference and improve the health of our obese peri- and postmenopausal women by recommending interventions that reduce the risk of endometrial cancer, thereby improving the health of our patients. ●

Endometrial cancer is the most common gynecologic ma­lignancy, with approximately 59,000 cases diagnosed annually,¹ and a lifetime risk of approximately 3.1% in the United States.² Type I endometrial cancer includes tumors with endometrioid histology that are grade 1 or 2. Type II endometrial cancer includes tumors that have grade 3 endometrioid or nonendometrioid histology, including serous, clear cell, mucinous, squamous transitional cell, mesonephric, and undifferentiated tumors.³ Type I endometrial cancer is hormone sensitive, generally stimulated by estrogen and suppressed by progestins.

Endometrial cancer is diagnosed at a mean age of 63 years,⁴ and only 15% of cases occur before age 50.⁵ Women with an elevated body mass index (BMI) have a markedly increased risk of both Types I and II endometrial cancer (TABLE).⁶ Hence, endometrial cancer is highly prevalent in obese postmenopausal women. For these women health interventions that may reduce the risk of developing endometrial cancer include dieting, physical activity, bariatric surgery, and progestin therapy.

Educating patients is a priority

Many women do not know that postmenopausal bleeding is a sign of endometrial cancer. All postmenopausal women should be advised that if they develop vaginal bleeding they need to be evaluated by a clinician.⁷ Women who are knowledgeable about the link between postmenopausal vaginal bleeding and endometrial cancer can be encouraged to share this information with their postmenopausal friends in order to reach more people with this important information. All obese postmenopausal women should be advised that weight loss and increased physical activity can reduce the risk of developing endometrial cancer.

How weight loss and physical activity affect risk

Intentional weight loss has been reported to reduce the risk of endometrial cancer in postmenopausal women. As part of the Women’s Health Initiative observational study, 36,794 postmenopausal women aged 50 to 79 years with a uterus had their body weight and height measured at entry into the study and after 3 years of follow-up.⁸ During the 11 years following study entry, there were 566 incident cases of endometrial cancer. Compared with women who had a stable weight, intentional weight loss of ≥5% was associated with a 40% reduction in the risk of endometrial cancer (hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.42–0.86). Compared with women who had a stable weight, women who had weight gain ≥10% had an increased risk of endometrial cancer (HR, 1.26; 95% CI, 1.00–1.57).

High levels of physical activity may be associated with a decreased risk of endometrial cancer. In one study, compared with a sedentary lifestyle, higher levels of physical activity were reported to be associated with a decreased risk of endometrial cancer.⁹

Continue to: How bariatric surgery affects risk...

Many cancers are associated with obesity, including endometrial, breast, colon, pancreas, gallbladder, and renal. Obesity is associated with increased conversion of androgens to estrogens in fat tissue, stimulating excessive endometrial proliferation and increasing the risk of endometrial hyperplasia and cancer. Bariatric surgery reliably causes sustained weight reduction. Multiple studies have reported that bariatric surgery reduces the risk of endometrial cancer.

Schauer and colleagues used data from the Kaiser Permanente health system to identify 22,198 obese people who had undergone bariatric surgery and 66,427 matched controls who were obese but did not have surgery.¹⁰ The study population was 81% female, with a mean age of 45 years and a mean BMI of 45 kg/m². After an average 3.5 years of follow-up there were 2,542 incident cases of cancer, including 322 cases of endometrial cancer. Compared with conventional weight loss treatment, bariatric surgery reduced the risk of endometrial cancer by 50% (HR, 0.50; 95% CI, 0.37–0.67; P<.001).¹⁰ In addition, bariatric surgery reduced the risk of colon and pancreatic cancer by 41% and 54%, respectively.¹⁰

In the Swedish Obese Subjects (SOS) study, 1,420 women who underwent bariatric surgery and 1,447 matched controls who received conventional obesity treatment were followed for 18 years.¹¹ At study entry, the mean age of the women was approximately 48 years, and the mean BMI was approximately 42 kg/m². In follow-up there were 76 incident cases of endometrial cancer. Compared with women receiving conventional obesity treatment, women who had bariatric surgery had a non–statistically significant 49% decrease in the risk of developing endometrial cancer (HR, 0.51; 95% CI, 0.24–1.10)

In a systematic review of 5 additional studies (not including publications 10 or 11) of the impact of bariatric surgery on the risk of developing endometrial cancer, the surgery was associated with a 68% risk reduction (odds ratio [OR], 0.32; 95% CI, 0.16–0.63) compared with matched obese women that did not have surgery.¹²

Although there are no randomized prospective studies showing that bariatric surgery reduces the risk of endometrial cancer, the weight of the observation evidence is strong. In addition, bariatric surgery was reported to reduce all-cause mortality in the SOS study.¹³ Hence, for obese postmenopausal women, if lifestyle changes do not result in sustained weight loss, bariatric surgery may be an optimal approach to improving health outcomes.

Continue to: Progestin treatment and endometrial cancer risk...

Estrogen stimulates endometrial cell proliferation. Hence, unopposed chronic exposure to estrogen is a major risk factor for developing endometrial hyperplasia and cancer. Progestins block the proliferative effect of estrogen and cause cell differentiation, resulting in stromal decidualization. Progestins also reduce the concentration of estrogen and progesterone receptors and increase the activity of enzymes that convert estradiol to estrone, blocking estrogen-induced endometrial proliferation.¹⁴

In women with endometrial hyperplasia, progestins have been shown to be effective in resolving the hyperplasia in approximately 80% of cases. Both oral progestins and the 52-mg levonorgestrel-containing intrauterine device (LNG-IUD) have been reported to be effective in the treatment of endometrial hyperplasia. In a Cochrane systematic review and meta-analysis, the 52-mg LNG-IUD was reported to be somewhat more effective in resolving endometrial hyperplasia than cyclic oral progestins (89% vs 72%, respectively).¹⁵

Other studies have also reported that the 52 mg LNG-IUD was more effective than oral progestin therapy for women with complex atypical endometrial hyperplasia.¹⁶ There are no large randomized clinical trials of progestin therapy on prevention for future development of endometrial cancer in obese postmenopausal women who have a normal endometrial histology. However, for an obese perimenopausal woman, insertion of a 52-mg LNG-IUD may help to minimize excessive uterine bleeding during the menopause transition and reduce the risk of developing endometrial hyperplasia during the early postmenopause.

We can help our patients reduce their risk of endometrial cancer

Obese postmenopausal women are at increased risk for developing endometrial cancer. Gynecologists play an important role in the prevention and early detection of endometrial cancer. We can make a difference and improve the health of our obese peri- and postmenopausal women by recommending interventions that reduce the risk of endometrial cancer, thereby improving the health of our patients. ●

In the 1990s, researchers found that patients undergoing any type of surgical procedure were more than twice as likely to die if they developed postsurgical infection.¹ Work to reduce surgical site infection (SSI) has and does continue, with perioperative antibiotics representing a good part of that effort. The American College of Obstetricians and Gynecologists currently recommends such antibiotic therapy for women undergoing laparotomy and laparoscopic hysterectomy.² ACOG does not, however, recommend prophylactic antibiotics for myomectomy procedures.³ Rates of infection for hysterectomy have been reported to be 3.9% for abdominal and 1.4% for minimally invasive approaches.⁴

To determine the current use of antibiotics during myomectomy and associated rates of SSI at their institutions, Dipti Banerjee, MD, and colleagues conducted a retrospective analysis of women undergoing laparoscopic or abdominal myomectomy between February 2013 and December 2017 at the University of California, Los Angeles and Hoag Memorial Hospital in Orange County, California. They presented their study results at AAGL’s 49th Global Congress on MIGS, held virtually November 6-14, 2020.³

Rate of SSI after myomectomy

A total of 620 women underwent laparoscopic myomectomy and 563 underwent open myomectomy during the study period. Antibiotics were used in 76.9% of cases. SSI developed within 6 weeks of surgery in 34 women (2.9%) overall. The women undergoing abdominal myomectomy without antibiotics were more likely to experience SSI than the women who received antibiotics (odds ratio [OR], 4.89; confidence interval [CI], 1.80–13.27; P = .0006). For laparoscopic myomectomy, antibiotic use did not affect the odds of developing SSI (OR, 1.08; CI, 0.35–3.35).

Antibiotics were more likely to be used in certain cases

Antibiotics were more likely to be administered for patients who:

• were obese (body mass index ≥30 kg/m²) (P = .009)
• underwent previous abdominal surgery (P = .001)
• underwent laparotomy (P <.0001)
• had endometrial cavity entry (P <.0001)
• had >1 fibroid (P = .0004) or an aggregate fibroid weight >500 g (P <.0001).

More data on antibiotics for myomectomy

In a retrospective study conducted at 2 academic hospitals in Boston, Massachusetts, 1,211 women underwent myomectomy from 2009 to 2016. (Exclusions were use of vaginal or hysteroscopic myomectomy, chromopertubation, or conversion to hysterectomy.) More than 92% of the women received perioperative antibiotics at the time of surgery. Although demographics were similar between women receiving and not receiving antibiotics, women who received antibiotics were more likely to have longer operative times (median 140 vs 85 min), a greater myoma burden (7 vs 2 myomas removed and weight 255 vs 53 g), and lose blood during the procedure (137 vs 50 mL). These women also were 4 times less likely to have surgical site infection (adjusted OR, 3.77; 95% CI, 1.30–10.97; P = .015).^5,6

Banerjee and colleagues say that their California study demonstrates “that the majority of surgeons elect to use antibiotics prophylactically” during myomectomy, despite current ACOG guidelines, and that their findings of benefit for abdominal myomectomy but not for laparoscopic myomectomy should inform future guidance on antibiotics for myomectomy surgery.³

In the 1990s, researchers found that patients undergoing any type of surgical procedure were more than twice as likely to die if they developed postsurgical infection.¹ Work to reduce surgical site infection (SSI) has and does continue, with perioperative antibiotics representing a good part of that effort. The American College of Obstetricians and Gynecologists currently recommends such antibiotic therapy for women undergoing laparotomy and laparoscopic hysterectomy.² ACOG does not, however, recommend prophylactic antibiotics for myomectomy procedures.³ Rates of infection for hysterectomy have been reported to be 3.9% for abdominal and 1.4% for minimally invasive approaches.⁴

To determine the current use of antibiotics during myomectomy and associated rates of SSI at their institutions, Dipti Banerjee, MD, and colleagues conducted a retrospective analysis of women undergoing laparoscopic or abdominal myomectomy between February 2013 and December 2017 at the University of California, Los Angeles and Hoag Memorial Hospital in Orange County, California. They presented their study results at AAGL’s 49th Global Congress on MIGS, held virtually November 6-14, 2020.³

Rate of SSI after myomectomy

A total of 620 women underwent laparoscopic myomectomy and 563 underwent open myomectomy during the study period. Antibiotics were used in 76.9% of cases. SSI developed within 6 weeks of surgery in 34 women (2.9%) overall. The women undergoing abdominal myomectomy without antibiotics were more likely to experience SSI than the women who received antibiotics (odds ratio [OR], 4.89; confidence interval [CI], 1.80–13.27; P = .0006). For laparoscopic myomectomy, antibiotic use did not affect the odds of developing SSI (OR, 1.08; CI, 0.35–3.35).

Antibiotics were more likely to be used in certain cases

Antibiotics were more likely to be administered for patients who:

• were obese (body mass index ≥30 kg/m²) (P = .009)
• underwent previous abdominal surgery (P = .001)
• underwent laparotomy (P <.0001)
• had endometrial cavity entry (P <.0001)
• had >1 fibroid (P = .0004) or an aggregate fibroid weight >500 g (P <.0001).

More data on antibiotics for myomectomy

In a retrospective study conducted at 2 academic hospitals in Boston, Massachusetts, 1,211 women underwent myomectomy from 2009 to 2016. (Exclusions were use of vaginal or hysteroscopic myomectomy, chromopertubation, or conversion to hysterectomy.) More than 92% of the women received perioperative antibiotics at the time of surgery. Although demographics were similar between women receiving and not receiving antibiotics, women who received antibiotics were more likely to have longer operative times (median 140 vs 85 min), a greater myoma burden (7 vs 2 myomas removed and weight 255 vs 53 g), and lose blood during the procedure (137 vs 50 mL). These women also were 4 times less likely to have surgical site infection (adjusted OR, 3.77; 95% CI, 1.30–10.97; P = .015).^5,6

Banerjee and colleagues say that their California study demonstrates “that the majority of surgeons elect to use antibiotics prophylactically” during myomectomy, despite current ACOG guidelines, and that their findings of benefit for abdominal myomectomy but not for laparoscopic myomectomy should inform future guidance on antibiotics for myomectomy surgery.³

In the 1990s, researchers found that patients undergoing any type of surgical procedure were more than twice as likely to die if they developed postsurgical infection.¹ Work to reduce surgical site infection (SSI) has and does continue, with perioperative antibiotics representing a good part of that effort. The American College of Obstetricians and Gynecologists currently recommends such antibiotic therapy for women undergoing laparotomy and laparoscopic hysterectomy.² ACOG does not, however, recommend prophylactic antibiotics for myomectomy procedures.³ Rates of infection for hysterectomy have been reported to be 3.9% for abdominal and 1.4% for minimally invasive approaches.⁴

To determine the current use of antibiotics during myomectomy and associated rates of SSI at their institutions, Dipti Banerjee, MD, and colleagues conducted a retrospective analysis of women undergoing laparoscopic or abdominal myomectomy between February 2013 and December 2017 at the University of California, Los Angeles and Hoag Memorial Hospital in Orange County, California. They presented their study results at AAGL’s 49th Global Congress on MIGS, held virtually November 6-14, 2020.³

Rate of SSI after myomectomy

A total of 620 women underwent laparoscopic myomectomy and 563 underwent open myomectomy during the study period. Antibiotics were used in 76.9% of cases. SSI developed within 6 weeks of surgery in 34 women (2.9%) overall. The women undergoing abdominal myomectomy without antibiotics were more likely to experience SSI than the women who received antibiotics (odds ratio [OR], 4.89; confidence interval [CI], 1.80–13.27; P = .0006). For laparoscopic myomectomy, antibiotic use did not affect the odds of developing SSI (OR, 1.08; CI, 0.35–3.35).

Antibiotics were more likely to be used in certain cases

Antibiotics were more likely to be administered for patients who:

• were obese (body mass index ≥30 kg/m²) (P = .009)
• underwent previous abdominal surgery (P = .001)
• underwent laparotomy (P <.0001)
• had endometrial cavity entry (P <.0001)
• had >1 fibroid (P = .0004) or an aggregate fibroid weight >500 g (P <.0001).

More data on antibiotics for myomectomy

In a retrospective study conducted at 2 academic hospitals in Boston, Massachusetts, 1,211 women underwent myomectomy from 2009 to 2016. (Exclusions were use of vaginal or hysteroscopic myomectomy, chromopertubation, or conversion to hysterectomy.) More than 92% of the women received perioperative antibiotics at the time of surgery. Although demographics were similar between women receiving and not receiving antibiotics, women who received antibiotics were more likely to have longer operative times (median 140 vs 85 min), a greater myoma burden (7 vs 2 myomas removed and weight 255 vs 53 g), and lose blood during the procedure (137 vs 50 mL). These women also were 4 times less likely to have surgical site infection (adjusted OR, 3.77; 95% CI, 1.30–10.97; P = .015).^5,6

Banerjee and colleagues say that their California study demonstrates “that the majority of surgeons elect to use antibiotics prophylactically” during myomectomy, despite current ACOG guidelines, and that their findings of benefit for abdominal myomectomy but not for laparoscopic myomectomy should inform future guidance on antibiotics for myomectomy surgery.³

[polldaddy:10665862]

[polldaddy:10665862]

[polldaddy:10665862]

The state of Tennessee, where I worked and attended medical school, did not have legislation in place prohibiting termination of employment based on sexual orientation alone. As a lesbian, I never felt safe at work knowing that I could be fired at any time simply because of who I loved and how I identified. When I started medical school in rural Appalachia, I decided I would be “out” but remained cautious. That meant inspecting everyone I encountered for signs of acceptance and safety before sharing details about my life. As a third-year medical student, I started wearing a rainbow triangle on my white coat. One of the first patients I cared for cried and thanked me for wearing the pin. She then proceeded to tell me about her partner, her own struggles with depression, and the secrets she had to keep from her community. It was overwhelming and, yet, so familiar. I was struck by how wearing this pin, a small gesture, made this patient feel safe enough to come out to me and seek help for her depression. Although I found a supportive community in Tennessee, it was only after I moved to Massachusetts for residency—where antidiscrimination laws protected lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual, plus all other gender and sexual minority (LGBTQIA+) identified people—did I feel safe to freely share about my partner and our life together.

A landmark decision in the Supreme Court

This past June, in a 6 to 3 decision, the US Supreme Court ruled in the case of Bostock v Clayton County that Title VII’s ban on discrimination also protects LGBTQIA+ employees. Title VII is a federal law that protects employees from discrimination based on race, color, national origin, sex, and religion.¹ In this decision, the court determined that “sex” cannot be differentiated from sexual orientation. Justice Neil Gorsuch, who wrote the majority opinion, stated, “It is impossible… to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex.”² Title VII not only protects employees in hiring and firing practices but also protects against harassment and retaliation. Prior to this ruling, there were no federal antidiscrimination laws for LGBTQIA+ individuals, and only 22 states and the District of Columbia had laws in place that specified antidiscrimination protection for this community.³ Because of this landmark decision, Title VII now protects all employees in all states from discrimination, including due to an individual’s sexual orientation.

This is a huge victory in the battle for equality; however, the fight is not over. Justice Gorsuch stated, “We do not purport to address bathrooms, locker rooms or anything else of the kind…whether other policies and practices might or might not qualify as unlawful discrimination or find justifications under other provisions of Title VII are questions for future cases, not these.”² This victory sets a new precedent and will continue to be further defined with more court cases as states and employers push back against these protections.

Continue to: A worrying shift in the Court...

A worrying shift in the Court

We have already started to see the repercussions of this ruling from Supreme Court justices themselves. Justice Clarence Thomas, who dissented in the Obergefell v Hodges decision in 2015, which established the constitutional right for marriage equality, recently wrote a petition to have the Supreme Court reconsider that ruling. He wrote “Obergefell enables courts and governments to brand religious adherents who believe that marriage is between one man and one woman as bigots, making their religious liberty concerns that much easier to dismiss.”³ After the passing of Justice Ruth Bader Ginsburg, the Supreme Court became decidedly more conservative with the appointment of Judge Amy Coney Barrett, whose mentor was the late Justice Antonin Scalia, who also dissented in the 2015 case.

As we celebrate this huge win for equality in this June decision, we also must recognize that LGBTQIA+ rights are still at risk.

LGBTQIA+ patients at higher risk for litany of conditions

Even with the Bostock v Clayton County ruling, we must not forget that discrimination will continue to exist. As health care providers, we have a responsibility to advocate on behalf of our LGBTQIA+ colleagues and patients. According to the Healthy People 2020 survey, there are higher rates of obesity, tobacco dependence, and sexually transmitted infection, as well as lower adherence to cancer screening recommendations in the LGBTQIA+ community.⁴ These disparities are a result of systemic, legal, and social factors, including limited access to affirming and inclusive health care.⁵ The LGBTQIA+ community deserves better.

Take action

In the coming months and years, as the US Supreme Court hears more cases that will threaten the rights of the LGBTQIA+ community, I challenge all clinicians to take action. Even the smallest of gestures, such as wearing a rainbow pin, can be transformative for our patients and within our communities.

• Advocate for your state to enact nondiscrimination laws protecting the LGBTQIA+ community. Find out if your state has a law.
• Support your LGBTQIA+ colleagues by establishing an employee support group.
• Educate yourself and your colleagues on LGBTQIA+ inclusive medical practices.

The state of Tennessee, where I worked and attended medical school, did not have legislation in place prohibiting termination of employment based on sexual orientation alone. As a lesbian, I never felt safe at work knowing that I could be fired at any time simply because of who I loved and how I identified. When I started medical school in rural Appalachia, I decided I would be “out” but remained cautious. That meant inspecting everyone I encountered for signs of acceptance and safety before sharing details about my life. As a third-year medical student, I started wearing a rainbow triangle on my white coat. One of the first patients I cared for cried and thanked me for wearing the pin. She then proceeded to tell me about her partner, her own struggles with depression, and the secrets she had to keep from her community. It was overwhelming and, yet, so familiar. I was struck by how wearing this pin, a small gesture, made this patient feel safe enough to come out to me and seek help for her depression. Although I found a supportive community in Tennessee, it was only after I moved to Massachusetts for residency—where antidiscrimination laws protected lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual, plus all other gender and sexual minority (LGBTQIA+) identified people—did I feel safe to freely share about my partner and our life together.

A landmark decision in the Supreme Court

This past June, in a 6 to 3 decision, the US Supreme Court ruled in the case of Bostock v Clayton County that Title VII’s ban on discrimination also protects LGBTQIA+ employees. Title VII is a federal law that protects employees from discrimination based on race, color, national origin, sex, and religion.¹ In this decision, the court determined that “sex” cannot be differentiated from sexual orientation. Justice Neil Gorsuch, who wrote the majority opinion, stated, “It is impossible… to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex.”² Title VII not only protects employees in hiring and firing practices but also protects against harassment and retaliation. Prior to this ruling, there were no federal antidiscrimination laws for LGBTQIA+ individuals, and only 22 states and the District of Columbia had laws in place that specified antidiscrimination protection for this community.³ Because of this landmark decision, Title VII now protects all employees in all states from discrimination, including due to an individual’s sexual orientation.

This is a huge victory in the battle for equality; however, the fight is not over. Justice Gorsuch stated, “We do not purport to address bathrooms, locker rooms or anything else of the kind…whether other policies and practices might or might not qualify as unlawful discrimination or find justifications under other provisions of Title VII are questions for future cases, not these.”² This victory sets a new precedent and will continue to be further defined with more court cases as states and employers push back against these protections.

Continue to: A worrying shift in the Court...

A worrying shift in the Court

We have already started to see the repercussions of this ruling from Supreme Court justices themselves. Justice Clarence Thomas, who dissented in the Obergefell v Hodges decision in 2015, which established the constitutional right for marriage equality, recently wrote a petition to have the Supreme Court reconsider that ruling. He wrote “Obergefell enables courts and governments to brand religious adherents who believe that marriage is between one man and one woman as bigots, making their religious liberty concerns that much easier to dismiss.”³ After the passing of Justice Ruth Bader Ginsburg, the Supreme Court became decidedly more conservative with the appointment of Judge Amy Coney Barrett, whose mentor was the late Justice Antonin Scalia, who also dissented in the 2015 case.

As we celebrate this huge win for equality in this June decision, we also must recognize that LGBTQIA+ rights are still at risk.

LGBTQIA+ patients at higher risk for litany of conditions

Even with the Bostock v Clayton County ruling, we must not forget that discrimination will continue to exist. As health care providers, we have a responsibility to advocate on behalf of our LGBTQIA+ colleagues and patients. According to the Healthy People 2020 survey, there are higher rates of obesity, tobacco dependence, and sexually transmitted infection, as well as lower adherence to cancer screening recommendations in the LGBTQIA+ community.⁴ These disparities are a result of systemic, legal, and social factors, including limited access to affirming and inclusive health care.⁵ The LGBTQIA+ community deserves better.

Take action

In the coming months and years, as the US Supreme Court hears more cases that will threaten the rights of the LGBTQIA+ community, I challenge all clinicians to take action. Even the smallest of gestures, such as wearing a rainbow pin, can be transformative for our patients and within our communities.

• Advocate for your state to enact nondiscrimination laws protecting the LGBTQIA+ community. Find out if your state has a law.
• Support your LGBTQIA+ colleagues by establishing an employee support group.
• Educate yourself and your colleagues on LGBTQIA+ inclusive medical practices.

The state of Tennessee, where I worked and attended medical school, did not have legislation in place prohibiting termination of employment based on sexual orientation alone. As a lesbian, I never felt safe at work knowing that I could be fired at any time simply because of who I loved and how I identified. When I started medical school in rural Appalachia, I decided I would be “out” but remained cautious. That meant inspecting everyone I encountered for signs of acceptance and safety before sharing details about my life. As a third-year medical student, I started wearing a rainbow triangle on my white coat. One of the first patients I cared for cried and thanked me for wearing the pin. She then proceeded to tell me about her partner, her own struggles with depression, and the secrets she had to keep from her community. It was overwhelming and, yet, so familiar. I was struck by how wearing this pin, a small gesture, made this patient feel safe enough to come out to me and seek help for her depression. Although I found a supportive community in Tennessee, it was only after I moved to Massachusetts for residency—where antidiscrimination laws protected lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual, plus all other gender and sexual minority (LGBTQIA+) identified people—did I feel safe to freely share about my partner and our life together.

A landmark decision in the Supreme Court

This past June, in a 6 to 3 decision, the US Supreme Court ruled in the case of Bostock v Clayton County that Title VII’s ban on discrimination also protects LGBTQIA+ employees. Title VII is a federal law that protects employees from discrimination based on race, color, national origin, sex, and religion.¹ In this decision, the court determined that “sex” cannot be differentiated from sexual orientation. Justice Neil Gorsuch, who wrote the majority opinion, stated, “It is impossible… to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex.”² Title VII not only protects employees in hiring and firing practices but also protects against harassment and retaliation. Prior to this ruling, there were no federal antidiscrimination laws for LGBTQIA+ individuals, and only 22 states and the District of Columbia had laws in place that specified antidiscrimination protection for this community.³ Because of this landmark decision, Title VII now protects all employees in all states from discrimination, including due to an individual’s sexual orientation.

This is a huge victory in the battle for equality; however, the fight is not over. Justice Gorsuch stated, “We do not purport to address bathrooms, locker rooms or anything else of the kind…whether other policies and practices might or might not qualify as unlawful discrimination or find justifications under other provisions of Title VII are questions for future cases, not these.”² This victory sets a new precedent and will continue to be further defined with more court cases as states and employers push back against these protections.

Continue to: A worrying shift in the Court...

A worrying shift in the Court

We have already started to see the repercussions of this ruling from Supreme Court justices themselves. Justice Clarence Thomas, who dissented in the Obergefell v Hodges decision in 2015, which established the constitutional right for marriage equality, recently wrote a petition to have the Supreme Court reconsider that ruling. He wrote “Obergefell enables courts and governments to brand religious adherents who believe that marriage is between one man and one woman as bigots, making their religious liberty concerns that much easier to dismiss.”³ After the passing of Justice Ruth Bader Ginsburg, the Supreme Court became decidedly more conservative with the appointment of Judge Amy Coney Barrett, whose mentor was the late Justice Antonin Scalia, who also dissented in the 2015 case.

As we celebrate this huge win for equality in this June decision, we also must recognize that LGBTQIA+ rights are still at risk.

LGBTQIA+ patients at higher risk for litany of conditions

Even with the Bostock v Clayton County ruling, we must not forget that discrimination will continue to exist. As health care providers, we have a responsibility to advocate on behalf of our LGBTQIA+ colleagues and patients. According to the Healthy People 2020 survey, there are higher rates of obesity, tobacco dependence, and sexually transmitted infection, as well as lower adherence to cancer screening recommendations in the LGBTQIA+ community.⁴ These disparities are a result of systemic, legal, and social factors, including limited access to affirming and inclusive health care.⁵ The LGBTQIA+ community deserves better.

Take action

In the coming months and years, as the US Supreme Court hears more cases that will threaten the rights of the LGBTQIA+ community, I challenge all clinicians to take action. Even the smallest of gestures, such as wearing a rainbow pin, can be transformative for our patients and within our communities.

• Advocate for your state to enact nondiscrimination laws protecting the LGBTQIA+ community. Find out if your state has a law.
• Support your LGBTQIA+ colleagues by establishing an employee support group.
• Educate yourself and your colleagues on LGBTQIA+ inclusive medical practices.

OBG Manag. 2020 November; 32(11).

The Fetal Pillow: A new option for delivering the deeply impacted fetal head

Robert L. Barbieri, MD

(Editorial; July 2020)

Alternative option to the Fetal Pillow

I enjoyed Dr. Barbieri’s editorial on the Fetal Pillow. I worry, however, that applying high air pressure to the upper vagina could result in an air embolism.

I have experienced good results using a vacuum cup. Like the pillow, it distributes the force more evenly than a hand. Also, the handle makes elevation of the vertex much less awkward and allows elevation to a higher station. Whatever approach is employed, using an open internal monitor catheter allows for a gentler procedure than when brute force alone is used to “break the seal” to allow ingress of air into the uterine cavity (at just 1 atmosphere of pressure).

John H. Sand, MD

Ellensburg, Washington

Cost of device must be considered

The information on the Fetal Pillow in Dr. Barbieri’s timely editorial, while limited in scope, does make the device look like a promising option.

One of my institution’s biggest issues relates to cost. We have had some interest in incorporating the Fetal Pillow into our practice, and we have been quoted a rate of about $600.00 per device. I had our Fetal Pillow representative look into reimbursement and have been informed that, at least in our region, there has been no reimbursement for the cost.

When I look at the cost of a hospital stay for a normal spontaneous vaginal delivery (NSVD), the cost of the Fetal Pillow would actually add 15% to 20% to that stay. Now, one must consider also the cost of extension of the uterine incision versus the cost of the Fetal Pillow. When we did a superficial look at when the Fetal Pillow might be used versus how many uterine extensions we experienced, the cost of the Fetal Pillow over a year far exceeded the cost of the uterine extensions. Without reimbursement, this appeared unsustainable. It has been interesting as some sites had no awareness of cost and the fact that essentially “the system” was absorbing those costs.

This issue is worthy of thought but likely one that most obstetricians will not consider.

Casey Morris, MD

Downers Grove, Illinois

Tip for dislodging the fetal head

I read Dr. Barbieri’s editorial regarding the Fetal Pillow and would like to share my experience. Over the last 30 years, I have used a simple trick. After entering the pelvic cavity, we push on the lower uterine segment toward the fundus prior to uterine incision. This helps dislodge the fetal head. Occasionally, you can feel the “pop” when the suction is broken, which sets the head free. We then proceed with the uterine incision and delivery of the head. We have had great success over the years, and the poor nurse does not have to go under the drapes.

Walter Kobasa Jr, MD

Wilmington, Delaware

Dr. Barbieri responds

I appreciate the recommendations and insights of Drs. Sand, Morris, and Kobasa. As I mentioned in the editorial on the Fetal Pillow, there are many clinical pearls about management of a second stage, deep-transverse cephalic arrest at the time of cesarean delivery, including to extend or T the uterine incision, push with a hand from below, reverse breech extraction, use a Coyne spoon, administer nitroglycerine or terbutaline, break the vaginal suction before attempting delivery, and incise a Bandl ring. Dr. Sand adds vaginal placement of a vacuum cup to our armamentarium, and Dr. Kobasa recommends dislodging the fetal head with a push on the lower uterine segment before making the hysterotomy incision. I thank Dr. Morris for correcting my failure to report the cost of the Fetal Pillow, reporting a quoted price of $600 for each Fetal Pillow. I agree with Dr. Morris that physicians have an important responsibility to be good stewards of health care resources and weigh the benefits and costs of our decisions.

Continue to: In your practice, are you planning to have a chaperone present for all intimate examinations?

In your practice, are you planning to have a chaperone present for all intimate examinations?

Robert L. Barbieri, MD
(Editorial; June 2020)

Enough is enough

I have always thought that many doctors who write opinions and pontificate about what should be done in practice live in la-la land. This editorial, for me, confirms it.

I personally am becoming tired of all this: dividing the specialty into obstetricians and gynecologists; pelvic exams are not necessary during annual visits; HPV testing by patients at home; doing away with Pap smears; Pap smears are not necessary for patients after a certain age; scribes in your footsteps to document all findings in the EMR; heaven forbid you do not ask the patient if she has a fire extinguisher in her house or some other stupid information; interpreters for people who speak Mongolian because their partner should not be used to interpret for them; and so on.

Now you want us to have a chaperone for every pelvic exam! Not any chaperone, but a specialized one! You worry about the sanctity and privacy of the patient but now have 2 additional people in the room for the patient’s exam. First, most patients prefer to have the least number of people looking at their bodies during an exam, especially a pelvic exam. Second, where do we get the money to support all of this? Does this type of policy make any sense? Are lawyers now controlling what medical care is all about? Is that what is now considered quality medical care?

By the way, I am not a burned out physician. I use common sense and consider what is best for my patients in everything that I do. If a patient requests a chaperone, my medical assistant will come to the room and provide that service. You do not need to be specialized to provide this service! Ivory tower people have lost all common sense. You consider yourselves the authorities in whatever medical field you specialize in, but let me tell you something: You really are not.

I know I will be criticized and demonized publicly by many; however, I have the courage to say what, in my opinion, I feel is right and what is wrong. Many physicians are afraid to do so, and, like sheep, will comply with your misguided opinions. I truly do not mean any disrespect to your knowledge and good intentions. I just think that enough is enough!

Gabriel G. Hakim, MD

Waterbury, Connecticut

Dr. Barbieri responds

In response to my editorial on the American College of Obstetricians and Gynecologists (ACOG) recommendation that chaperones be present for intimate examinations (ACOG Committee Opinion No. 796), Dr. Hakim outlines many concerns with the rapidly evolving practice of medicine.¹ I am confident that the ACOG Committee on Ethics wisely considered the benefits, costs, and unintended consequences of the recommendation. The United States Veterans Administration, the Royal College of Obstetricians and Gynaecologists, and the American College Health Association endorse a similar recommendation. I do not think the distinguished members of the committees who issued the recommendation “live in la-la land.”

Reference

1. American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.

OBG Manag. 2020 November; 32(11).

The Fetal Pillow: A new option for delivering the deeply impacted fetal head

Robert L. Barbieri, MD

(Editorial; July 2020)

Alternative option to the Fetal Pillow

I enjoyed Dr. Barbieri’s editorial on the Fetal Pillow. I worry, however, that applying high air pressure to the upper vagina could result in an air embolism.

I have experienced good results using a vacuum cup. Like the pillow, it distributes the force more evenly than a hand. Also, the handle makes elevation of the vertex much less awkward and allows elevation to a higher station. Whatever approach is employed, using an open internal monitor catheter allows for a gentler procedure than when brute force alone is used to “break the seal” to allow ingress of air into the uterine cavity (at just 1 atmosphere of pressure).