Research roundup: October 2020 edition

IUD use and a demonstrated decreased risk of ovarian cancer, salpingectomy vs. tubal ligation for sterilization, benefits of non-medical treatment options for recurrent bacterial vaginosis, and more.

by Colleen Denny, MD and Emma Gilmore, MD

published 10/30/20

1. Access, Delivered/Plan C Provider Toolkit

In the setting of the COVID-19 pandemic, the delivery of abortion services has evolved as providers develop new strategies for patient evaluation and follow up. The FDA has loosened some of its regulations on in-person administration of mifepristone for medication abortion. As a result of these changes, the University of Washington paired with Plan C to develop a Provider Toolkit that includes information abortion providers need regarding legislation updates, state-based regulations, and abortion background. The document was created in part by family medicine physicians and the writers emphasize that abortion should be a primary care service. This is a highly useful and necessary document for all providers wishing to increase access to abortion, particularly during the pandemic through a primary care lens.

2. Ever-use of the intra-uterine device and the risk of ovarian cancer

Ovarian cancer is an uncommon but important cause of morbidity and mortality among people with ovaries, with most patients diagnosed at advanced stages of disease. While the use of combined oral contraceptives has been shown to reduce lifetime risk of ovarian cancer, it is unclear how different forms of contraception, particularly intrauterine devices (IUDs), may affect this lifetime risk. In this literature review, the authors identified nine studies examining the association between ever-use of an IUD and later diagnosis of ovarian cancer. They determined that there was a significant decrease, of approximately 30%, in the lifetime risk of ovarian cancer in patients who had ever used an IUD; this association was seen across cohort studies, case-control studies, and when the use of the levonorgestrel IUD was analyzed separately. While the etiology of this reduced risk is unclear and may be secondary to many factors, providers can counsel patients considering an IUD on this additional secondary benefit.

3. Salpingectomy versus tubal ligation for sterilization: a systematic review and meta-analysis

Tubal ligation, or removal of part of the fallopian tube, has historically been the preferred method for permanent sterilization. However, an improved understanding of gynecologic oncology has revealed that some forms of ovarian cancer originate in the fallopian tube and removal of the entire tube, known as a “salpingectomy,” can reduce a patient’s risk of developing ovarian cancer. This meta-analysis compares tubal ligation to salpingectomy for sterilization and found no clinical differences in blood loss, complications, or length of hospital stay. They appeared to be equally safe. One study found that salpingectomy was more effective at preventing pregnancy, though this did not reach statistical significance. These findings suggest that salpingectomy may ultimately become preferable, particularly when combined with the possible benefit of ovarian cancer prevention.

4. Non-antibiotic treatment of bacterial vaginosis-a systematic review

Bacterial vaginosis (BV) is a vaginal infection that can lead to significant adverse outcomes, including preterm delivery and increased risk of HIV acquisition. Although medical treatment for BV is well validated, there is a high recurrence rate, up to 69%. The reason for recurrence is not known but is hypothesized to be due to a persistent biofilm. With this in mind, the authors of this article conducted a review to evaluate non-medical options for treatment. Many of the included studies focused on both oral and vaginal administration of lactobacilli as there is some evidence that probiotics assist in recolonization of healthy vaginal flora and may help improve treatment outcomes. Reviewers found that due to the diversity among studied treatments, it was not possible to draw certain conclusions. However, non-medical options may have significant benefit for patients and their utilization warrants ongoing study.

5. Mifepristone Combination Therapy Compared With Misoprostol Monotherapy for the Management of Miscarriage: A Cost-Effectiveness Analysis. &

6. Management of early pregnancy loss with mifepristone and misoprostol: clinical predictors of treatment success from a randomized trial

While mifepristone has been approved by the FDA for use in medical abortion since coming on the market in 2001, recent data has indicated that its use for first trimester pregnancy failure (a.k.a. miscarriage) improves rates of successful medical management when compared with misoprostol management alone. This data led ACOG to officially recommend using a combination of mifepristone and misoprostol for first trimester miscarriage management in 2018.

However, given the higher cost of mifepristone, some providers have expressed concern that its routine use will raise costs for patients and practices, making improved success rates not cost-effective. In their cost-effectiveness analysis, Berkeley et al. examine how the costs of medications, travel, lost wages, and surgical management with dilation and curettage (D&C ) for treatment failures all affect management of first trimester miscarriage. They conclude that while the initial upfront cost of mifepristone adds significantly to the medication cost of misoprostol alone, the surgical costs of managing treatment failures more than counterbalance the costs of the medications, particularly when a D&C is performed in the operating room setting. Providers offering medical management for first trimester pregnancy loss can be confident that adding mifepristone will not only improve successful management rates, but also contribute to lower costs for the health care system and the patient .

Given that a certain percentage of patients with first trimester pregnancy loss will not be successfully managed even with combination therapy with mifepristone and misoprostol, researchers have also attempted to determine whether baseline characteristics of patients can predict successful management. Sonalkar et al performed a secondary analysis of previous RCT data showing the superiority of combination therapy versus misoprostol alone, examining whether patient factors such as parity, gestational age, bleeding at time of diagnosis, and type of early pregnancy failure were associated with increased rates of successful management with combination therapy. They did not find that any of these factors were significantly associated with increased success rates in the combination therapy arm, though there was a relatively small number of treatment failures overall in this treatment group. They conclude that the addition of mifepristone for medical miscarriage management should be considered across the board for patients, regardless of baseline characteristics.

7. Conception rates in women desiring pregnancy after levonorgestrel 52 mg intrauterine system (Liletta®) discontinuation

The levonorgestrel IUD is recognized as a highly effective form of birth control, but less is known about fertility rates after its removal, particularly for people who have never been pregnant. Some studies have suggested that patients may mistakenly believe that IUDs lead to infertility and difficulty with conception. The authors of this study followed a group of participants in the ACCESS IUS trial, which is a long-term Phase 3 trial evaluating the Liletta IUD, a 52-mg levonorgestrel IUD. Researchers followed trial participants who sought pregnancy in the 12 months after Liletta removal. They found a self-reported one-year conception rate of 86% for this cohort, which is similar to estimated fertility rates in the general population. Fertility rates did not vary based on parity or gravidity. These findings suggest that fertility returns after discontinuing a levonorgestrel IUD and attempt to become pregnant. Providers can confidently counsel patients who have questions about return of fertility after using a levonorgestrel IUD based on these findings.

8. Evaluation of clinical performance when intrauterine devices are inserted by different categories of healthcare professional

IUDs are known to be some of the most effective forms of birth control. However, many barriers to access exist, including myths about efficacy, logistical issues, and lack of provider training. A research team in Brazil noted that at 6%, IUD use in Latin America is lower than in many other parts of the world. Provider limitation is a specific problem for IUD utilization, as the Brazilian Ministry of Health prohibited providers other than physicians to place IUDs starting in December 2019. The authors of this paper noted that few studies have compared outcomes for different providers when placing IUDs, but when nurses are allowed to place IUDs use rates are higher. They conducted a retrospective cohort analysis to compare clinical performance for IUDs placed by physicians, nurses, and trainees in Brazil, prior to changes in legislation. Rates of expulsion were similar among the three groups, regardless of parity, and clinical outcomes were not different between groups. Overall, these findings suggest that authorizing different providers to place IUDs can help improve access.

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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