Research roundup: July 2020 edition

Society of Family Planning’s clinical recommendations for contraceptive counseling for transgender and gender-expansive patients, the positive effect of levonorgestrel IUDs on female sexual function, barriers to abortion care within religious hospital systems, and more.

by Colleen Denny, MD and Emma Gilmore, MD

published 07/31/20

1. The effects on ovarian activity of delaying versus immediately restarting combined oral contraception after missing three pills and taking ulipristal acetate 30 mg

There is existing evidence that Ulipristal acetate (UPA-EC, or ella) can delay the effectiveness of combined oral contraceptives (COCs) when patients restart the pill immediately after taking emergency contraception. Therefore, current recommendations advise patients to wait five days after taking UPA-EC before starting COCs. However, researchers in this study demonstrated that this five day delay may lead to ovulation for patients who were already on COCs prior to taking UPA-EC. Based on their findings, the authors suggest that if a patient is already on COCs, they should resume them directly after UPA-EC instead of waiting, to prevent the possibility of ovulation and increased risk for unplanned pregnancy. This finding should be considered when counseling patients about restarting COCs after taking emergency contraception. However, it is important to note that for patients who are starting COCs for the first time, the five day delay after UPA-EC is still supported by available evidence.

2. “My Hands Are Tied”: Abortion Restrictions and Providers’ Experiences in Religious and Nonreligious Health Care Systems

In 2019, the US Department of Health and Human Services issued protections to providers and institutions wishing to withhold health services for religious reasons. Barriers to abortion within Catholic hospital systems are well-documented, but these issues are less clearly understood in the context of Protestant or secular health care institutions. In this landscape of legislative obstacles, the authors of this study compared the experiences of providers in Catholic, Protestant, and secular hospitals, specifically with regard to abortion services. Results suggest that there is a lack of clear messaging from hospitals with limited abortion services, and that care may be significantly delayed by involvement of ethics consults and other religious advisors. Furthermore, patients are often unprepared for the degree of difficulty they may face in obtaining an abortion at a religious institution. They are less likely to face these obstacles when they seek care at secular hospitals. The authors conclude that greater transparency about services offered may allow patients to obtain abortions with less delay, and that religious hospital systems need greater oversight as their restrictions may severely impact health outcomes for patients seeking abortion.

3. A repeat dose of misoprostol 800 mcg following mifepristone for outpatient medical abortion at 64–70 and 71–77 days of gestation: A retrospective chart review

The combination of mifepristone and misoprostol for medication abortion has been proven safe and effective in the first trimester and is currently FDA-approved through 70 days of gestation. However, the rate of successful complete abortion with this regimen decreases with increasing gestational age, with reported ongoing pregnancy rates of up to 9% after 70 days. In this retrospective chart review, the authors identified more than 600 patients between 64 and 77 days of gestation who received a modified medication abortion regimen, with 200 mifepristone orally followed in 24-48 hours by 800mcg of misoprostol buccally and then another 800mcg sublingually, 4 hours apart. Successful completion occurred in 99.6% of the patients at 64-70 days, and 97.7% at 71-77 days; however, approximately 25% of patients were lost to follow up. Despite high attrition rates, this study suggests that a repeat dosing of misoprostol may improve efficacy rates of medical abortion in the late first trimester.

4. Society of Family Planning clinical recommendations: Contraceptive counseling for transgender and gender diverse people who were female sex assigned at birth

In these Clinical Recommendations from the Society of Family Planning, the authors attempt to address the dearth of information about contraceptive use for transgender and gender diverse (TGD) people assigned female sex at birth. The authors discuss the spectrum of surgical and medical therapies that TGD people may use, as well as how TGD people who desire to either become pregnant or avoid pregnancy may face unique challenges. They review the use of contraception for TGD populations, including those patients using hormonal therapy, and discuss techniques for counseling, interviewing, and examinations that make health care experiences more welcoming to TGD patients.

5. Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: A Randomized Controlled Trial

The etonogestrel implant (Nexplanon) is a highly effective and reversible form of contraception, but implant users often report unacceptable bleeding patterns as a leading reason for early discontinuation. In this randomized placebo-controlled study, the authors investigated whether a course of tamoxifen could improve bleeding patterns and patient satisfaction for slightly more than 100 Nexplanon users with frequent or prolonged bleeding. Patients in the treatment group received 10mg tamoxifen twice daily for one week after more than three days of bleeding. In their results, the authors found that the treatment group reported both more consecutive days of amenorrhea and more total days of no bleeding, as well as higher satisfaction rates than the control group. For patients with undesirable bleeding patterns using Nexplanon, a short course of tamoxifen may provide at least a short-term improvement.

6. Progestogen-releasing intrauterine systems for heavy menstrual bleeding

In this Cochrane review, the authors examine the use of levonorgestrel IUDs to improve heavy menstrual bleeding. They identified 25 trials including more than 2500 patients that compared levonorgestrel IUDs to other hormonal therapies, endometrial resection/ablation, or hysterectomy. In reviewing the trials, the authors noted that the quality of the evidence was overall limited. However, they concluded that the levonorgestrel IUD may improve heavy menstrual bleeding and quality of life in comparison to other medical therapies with similar rates of adverse events and was likely similar to endometrial destruction techniques with a greater likelihood of adverse events. They were unable to determine the relative benefit of these IUDs in comparison with hysterectomy. For patients who prefer to manage their heavy menstrual bleeding medically, providers may want to consider levonorgestrel IUDs as a first approach.

7. The effect of a levonorgestrel-releasing intrauterine device on female sexual function

Levonorgestrel IUDs provide highly effective contraception but attempts to understand their overall effect on users’ sexual function have met with mixed results. In this cross-sectional study, the authors administered the validated Female Sexual Function Index (FSFI) questionnaire to approximately 150 patients immediately prior to IUD insertion and then six months later. They found that overall FSFI scores significantly increased among patients at the six month interval and noted that patients reported improvements in subdimensions of the questionnaire investigating desire, arousal, orgasm, lubrication, and pain. While these improvements may represent a multifactorial process, including stabilizing hormone levels and decreasing abnormal uterine bleeding, the results match other similar studies of the effect of levonorgestrel IUDs on sexual function. Providers discussing these IUDs with their patients can reassure them about the lack of negative effect (and likely positive effect) on their sex lives.

8. 10% lidocaine spray for pain control during intrauterine device insertion: a randomised, double-blind, placebo-controlled trial

While copper IUDs can provide a highly effective, hormone-free form of contraception, pain at time of insertion may be a significant deterrent to patients. In this randomized control trial, the authors investigated whether the use of topical lidocaine spray could improve patients’ reported pain. They found that patients’ reported pain scores in the treatment group were lower for several parts of the insertion, including tenaculum placement, uterine sounding, and immediately after IUD placement. If available, providers can consider using 10% lidocaine spray to improve the comfort of patients undergoing copper IUD placement.

9. Elevated Risk of Bacterial Vaginosis Among Users of the Copper Intrauterine Device: A Prospective Longitudinal Cohort Study

Some studies have shown that the copper intrauterine device (Cu-IUD) may lead to an increased risk of bacterial vaginosis (BV). The mechanism of this risk is unknown but may be related to the presence of a foreign body within the uterus, or the longer duration of menses that some individuals experience with the Cu-IUD. For this study, researchers sought to better understand the relationship between Cu-IUDs and BV. A large prospective secondary analysis was performed of 2585 African women who were part of a large multi-center study on contraceptive methods. The authors found that women using the Cu-IUD had a 28% greater risk of having bacterial vaginosis through up to 18 months of IUD use. This risk then returned to baseline after removal of the Cu-IUD. There was no additional risk noted with individuals who were using progestin-only methods. This information suggests that there may indeed be an additional BV risk with the Cu-IUD and adds to the growing body of literature on this topic. Based on this finding, providers may want to integrate this information into their counseling sessions with patients.

10. Levonorgestrel-Releasing Intrauterine System as a Contraceptive Method in Nulliparous Women: A Systematic Review

The levonorgestrel-releasing intrauterine system (LNG-IUS) has gained wide use for individuals seeking long-acting reversible contraception (LARC). However, there is a large and increasing body of literature on its acceptability for nulliparous women, and many providers may find it intimidating to sift through this information. The authors of this study sought to summarize relevant data by performing a systematic review of all available evidence on the LNG-IUS and its use in nulliparous individuals. They considered efficacy, safety/side effects, bleeding pattern, and continuation rates. Overall, they found that the LNG-IUS is highly effective for nulliparous women. Expulsion rates were lower for nulliparous than parous women. While some patients noted irregularity in bleeding pattern (particularly for the first months of use), this was not significantly bothersome. Finally, there were high continuation and satisfaction rates for nulliparous users of the LNG-IUS. Overall, this review supplies providers with a summary of evidence supporting LNG-IUS use in nulliparous individuals and is a handy reference for patient counseling and questions.

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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