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Research roundup: June 2022 edition

Effective emergency contraception for individuals with obesity, the need for a reproductive justice lens in contraceptive counseling, a new treatment for bacterial vaginosis, and more. 

by Colleen Denny, MD and Emma Gilmore, MD

published 06/30/22

1. Double Dosing Levonorgestrel-Based Emergency Contraception for Individuals With Obesity

Oral emergency contraception (EC) with LNG, which is available OTC, is a potentially important option for patients who have unprotected or underprotected intercourse and do not desire pregnancy. However, the standardly available dose for LNG EC (1.5mg) is known to be less effective in patients with higher BMIs. With evidence that for individuals weighing more than 80kg, a 1.5mg dose of LNG used as EC is not superior to a placebo. In this randomized controlled trial, researchers recruited 70 patients with BMIs greater than 30 and studied whether ovulation was suppressed with the use of 3mg of LNG, compared to the standard dose of 1.5mg. The authors found that there was no difference in the two groups with either no follicle rupture (blocked ovulation) or time to follicle rupture (delayed ovulation). Given that LNG EG works through delaying ovulation, the authors concluded that a straightforward doubling of the EC LNG dose could not be used to increase EC efficacy in patients with a BMI greater than 30 and that ulipristal acetate pills (or an IUD) should continue to be preferentially recommended for these patients.

2. Comprehension of an Over-the-Counter Drug Facts Label Prototype for a Mifepristone and Misoprostol Medication Abortion Product

Medication abortion, administered as a combination of mifepristone and misoprostol, is a safe and effective method of abortion. Despite numerous barriers to over-the-counter (OTC) provision of these medications, there is evidence to support such an initiative: the medications are safe, unlikely to be abused, and the majority of patients do not need an ultrasound or laboratory testing before taking them. In order to transition a medication to OTC availability, the US Food and Drug Administration (FDA) requires evidence demonstrating label safety and comprehension. With this goal in mind, the authors of this study developed the prototype of a drug label for a combined mifepristone-misoprostol OTC product and conducted a study to assess understanding of label concepts among patients. First, the authors worked with an interdisciplinary group to create a label prototype, featuring numerous objectives including medication efficacy, safety, and warning signs. Next, they recruited interview subjects and conducted more than 800 interviews to assess comprehension of key concepts. Overall, they found that participants had a high level of comprehension of facts when reading a drug label, and only recommended a small number of edits. These findings suggest that OTC medication abortion, with a carefully crafted and evidence-based label, could result in a high level of understanding by patients.

3. Doctor knows best? Provider bias in the context of contraceptive counseling in the United States

When it comes to contraceptive counseling, prior research has shown that provider bias may result in counseling that conflicts with patients’ desires or wishes. This is particularly of concern when patients are vulnerable to providers’ stereotypes regarding their age, socioeconomic status, and race or ethnicity. As a result, it is important for medical systems to examine the ways that they provide contraceptive counseling and assess the presence and influence of implicit bias and stereotypes. Reproductive justice is a critical framework that redefines the provision of reproductive health care, centering patients’ rights to autonomy. With this in mind, the authors of this paper performed a qualitative study using a reproductive justice lens, interviewing 15 providers in obstetrics and gynecology in South Carolina. The group of participants included 11 physicians and four nurses, and all were white/Caucasian. The authors identified multiple themes of bias related to patients’ age, socioeconomic status, and race or ethnicity. The participants also seemed to have limited understanding of reproductive justice or insight into the way that systemic racism and bias may affect patients seeking contraceptive counseling. This study highlights a need for reproductive justice education and training for sexual and reproductive health care providers.

4. Levonorgestrel 52 mg intrauterine system efficacy and safety through 8 years of use

IUDs and implants may be preferred forms of birth control for individuals who hope to use a trustworthy method over the course of many years. Extending the known duration of effectiveness for these methods allow individuals to gain even more time before they need to see a health care provider for replacement—a process that can be time-consuming and burdensome. An IUD with 52mg of levonorgestrel (Liletta or Mirena) has previously been shown to be effective for seven years. However, the full longevity of these IUDs is not yet known. The authors of this study tracked the efficacy and patient outcomes of a 52mg levonorgestrel IUD for up to eight years as part of a large phase 3 multi-center trial. The 343 patients who completed eight years with the IUD in place had very low rates of pregnancy or other adverse outcomes. This study found that the 52mg levonorgestrel IUD was effective and safe for up to eight years of use, with a pregnancy rate of 1% over the full duration of use. This is important information for providers and patients as they consider the appropriate timeline for removal or replacement of this IUD.

5. An intersectional analysis of contraceptive types chosen among sexual minority women: A nationally representative study

Sexual minority women are defined as people who were assigned female at birth and are not exclusively heterosexual. Their self-defined sexual orientations may include lesbian, queer, and pansexual. These individuals experience unintended pregnancy at higher rates than their heterosexual peers, and data shows that they have unmet health needs, which may include disparities in access to birth control and reproductive healthcare. Furthermore, providers in obstetrics and gynecology may have limited familiarity with caring for this patient population, further reducing access and leading to alienation. Understanding behaviors around contraceptive use is important both for providers and anyone who hopes to create programs to assist vulnerable populations. The authors of this study used survey data to explore contraceptive use in sexual minority women, particularly as related to race and insurance status. They found that Black and Hispanic lesbian women, and Hispanic and other race bisexual women are less likely to use hormonal contraceptive methods as compared to their white lesbian and bisexual peers. Bisexual women were more likely to be uninsured than their lesbian or heterosexual peers. Overall, the information in this study adds insight that is fundamental to providing informed, nuanced care to this patient population.

6. Effects of Depot Medroxyprogesterone Acetate Intramuscular Injection, Copper Intrauterine Device and Levonorgestrel Implant Contraception on Estradiol Levels: An Ancillary Study of the ECHO Randomized Trial

Estrogens play important roles in many different physiological processes, and changes in estrogen serum levels have the potential to affect patients’ bone and heart health, vaginal biomes, and libidos. Patients using different forms of hormonal contraception experience changes in their serum estrogen levels and endogenous sex steroid hormone levels, but less is known about how different forms of contraception may have different impacts. In this ancillary study to the ECHO study, which randomized patients to copper IUD, LNG implant, or depot medroxyprogesterone acetate (DMPA) injection use and followed them for 12 to 18 months, the authors studied how serum estrogen levels varied between the three groups at six months of use. Among the approximately 400 patients for which comparison data was available, the authors found that estrogen levels were unchanged in the IUD users at six months, but that the DMPA group and LNG implant groups had estrogen levels 53% and 48% lower than IUD users, respectively. In their discussion, the authors noted that other analyses had reported that sexual activity levels were lower in the DMPA and implant groups, and that this could potentially be associated with the lower estrogen levels seen in these groups. Providers offering hormonal contraception to patients who are concerned about the effects on sexual function can use this data further discuss the complex relationship between libido and contraception use.

7. Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis

Heavy menstrual bleeding (HMB) is defined as menstrual bleeding that affects a person’s quality of life, regardless of actual volume of bleeding, and is thought to affect between 20-50% of all menstruating individuals. In this Cochrane review, the authors reviewed publications on both medical and surgical interventions for HMB in regard to the primary outcomes of bleeding and patient satisfaction. In reviewing nine systematic reviews that included 104 primary studies with nearly 12,000 patients, the authors examined both first-line interventions (medical, including LNG IUD) and second-line interventions (surgical or procedural). The authors concluded that LNG-IUD was the most effective first-line option for reducing menstrual blood loss, and that both antifibrinolytics and long cycle progestogens were also likely more effective than placebo. However, for patients who are surgical candidates, hysterectomy was the most effective second-line choice for reducing blood loss, and minimally invasive hysterectomy appeared to have higher patient satisfaction than LNG-IUD. While endometrial ablation may be more effective at reducing blood loss and have higher patient satisfaction than LNG-IUD use, data was low quality. The authors caution that their confidence in the available evidence was at best moderate and often low to very low but encouraged future research on these methods to determine optimal management for patients with HMB.

8. Awareness, knowledge, and misconceptions of adolescents and young people regarding long-acting reversible contraceptives: a systematic review and meta-analysis

While long-acting reversible contraception (LARCs), such as IUDs and implants, are approved for use for all individuals of reproductive age, adolescents and young adults are less likely to use contraception consistently and are particularly less likely to use these methods. In this systematic review, the authors identified 40 studies including more than 10,000 patients between 12-25 years old to assess younger patients’ knowledge and familiarity with these methods. Only 65% of patients could identify one LARC method, and misinformation was common with 62% of patients not understanding that IUDs could be used by nulliparous patients, and 37% of patients believing that LARCs could cause infertility. This study highlights the need for targeted education and counseling for sexually active young patients, especially regarding IUD and implant misinformation.

9. Effectiveness and Harms of Contraceptive Counseling and Provision Interventions for Women : A Systematic Review and Meta-analysis

Patients seeking to avoid pregnancy may face many types of barriers to access effective contraception, and individual providers and institutions often develop interventions to try to reduce these barriers. However, less research has sought to compare the effectiveness of these interventions directly. In this systematic review, the authors identified 38 trials including more than 25,000 patients to determine which interventions were associated with increased contraception use; interventions were defined as structured/enhanced counseling, specialized education materials, individualized information, decision support tools and computer modules, enhanced care after training of clinicians, onsite support services, provision of contraception at times/settings outside of routine practice, and/or referrals and follow up. The authors identified several strategies that appeared to enhance successful contraception use long-term, including advance provision of EC, contraception counseling at time of delivery or abortion, or interventions that included pharmacists. Potential harms of these interventions, such as increased STIs or decreased condom use, were not seen. Providers seeking to improve their contraception counseling can consider implementing some of the strategies shown to be effective in this review.

10. Single-Dose, Bioadhesive Clindamycin 2% Gel for Bacterial Vaginosis: A Randomized Controlled Trial

Bacterial vaginosis (BV) is a common condition affecting individuals with vaginas. Symptoms include vaginal itching, burning, or discharge, and untreated BV can result in increased risk of HIV transmission, adverse pregnancy outcomes, and other issues making effective and acceptable treatment a high priority. The authors of this study sought to evaluate the efficacy of a new, single-dose 2% of clindamycin gel, which has already been demonstrated to be safe and acceptable to patients with a longer course of treatment. They measured clinical cure rates 21 to 30 days after administration for this double-blind, placebo-controlled randomized controlled study of patients with BV, including those with recurrent BV. The authors found that the single-dose clindamycin gel was safe and significantly more effective than placebo for both intention-to-treat and per-protocol analyses, with a 70% cure rate. Overall, these findings suggest that this single-dose 2% clindamycin gel could be a safe and effective treatment for treating patients with BV.

Colleen Denny, MD, is an attending ObGyn at Bellevue Hospital in New York City, where she is the Medical Director of the Women's Clinic, and a clinical assistant professor with the NYU School of Medicine. She enjoys providing care for patients in all phases of life and is especially interested in issues related to contraception access and public health. Outside of work, she’s a runner, a dancer, and a bit of a crossword puzzle nerd.
Emma Gilmore is a fellow in Complex Family Planning at the University of Pennsylvania. She completed her residency in Obstetrics and Gynecology at New York University. She's passionate about reproductive rights, medical education, and combating health care disparities, particularly in sexual and reproductive health. In her free time, she can be found taking her dog on walks around the beautiful parks in and around Philadelphia.
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