Research roundup: January 2021 edition

Benefits of self-administered DMPA injections, an analysis of prophylactic pain management in medication abortion care, a need for ongoing education for providers on clinical indications for pelvic exams, the potential use of mifepristone as emergency contraception, and more.

by Colleen Denny, MD and Emma Gilmore, MD

published 01/29/21

1. Effectiveness, safety and acceptability of medical abortion at home versus in the clinic: a systematic review and meta-analysis in response to COVID-19.

Medication abortion is a safe and effective method for pregnancy termination well supported by evidence. However, numerous restrictions still exist limiting the number of patients who are able to access medication abortion, particularly while at home. In the setting of the COVID-19 pandemic, it has become increasingly urgent that reproductive care be available in ways that do not strain the health care system and provide patients with safe, accessible options. The authors of this study performed a systematic review and meta-analysis to compare home versus clinic-based medication abortion regarding effectiveness, safety, and accessibility. They found that there is no difference between home or clinic-based abortion on any of these metrics. Furthermore, those who had a medication abortion at home were more likely to comply with follow up protocols. Overall, this study provides support for offering medication abortions in the home setting, improving safe abortion access during the COVID-19 pandemic and beyond.

2. Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results

This article describes the Phase 3 clinical trial results for Twirla, a low-dose levonorgestrel/ethinyl estradiol patch that requires weekly dosing. This patch features lower doses of both progestin and estrogen than the patch currently on the market. This means Twirla poses a lower theoretical risk of thrombotic events in users. For this Phase 3 trial, more than two thousand patients were enrolled in a cohort that was deemed representative of US demographics; more than one-third had a BMI greater than or equal to 30. Researchers found that the patch was effective in preventing pregnancy in this population, but that efficacy was reduced in patients with a BMI greater than or equal to 30. The safety profile was similar to that of similar-dose contraceptives, with a very small number of thrombotic events noted only in the larger BMI group. Based on these results, this Phase 3 study supported FDA approval of the low-dose levonorgestrel/ethinyl estradiol patch for contraceptive use in patients with a BMI <30.

3. An implementation project to expand access to self-administered depot medroxyprogesterone acetate (DMPA)

Depot medroxyprogesterone acetate (DMPA) is a highly effective option for contraception and may be administered either as an intramuscular (IM) or subcutaneous (SQ) injection every three months. DMPA-SQ is currently FDA-approved only when injected by a health care professional, and many insurers do not cover it as a pharmacy benefit and/or require prior authorization. However, during the COVID-19 pandemic, California’s public health care program changed to allow coverage of DMPA-SQ as a pharmacy benefit allowing for increased access to self-administration. The authors took advantage of this to implement a patient outreach project, surveying current DMPA-IM users to assess interest and successful self-injection of DMPA-SQ. Of the 70 patients counseled on self-injection of DMPA-SQ, 37% expressed interest and 21% of the total successfully managed self-injection. This relatively small project indicates that a percentage of patients using DMPA for contraception would prefer a more patient-centered, self-controlled approach to DMPA using self-administered injections, which makes the case for this to become more widely available and covered by insurers. Want to learn more about how to talk to your patients about DMPA-SQ? Check out this provider guide!

4. Two prophylactic pain management regimens for medical abortion ≤63 days' gestation with mifepristone and misoprostol: A multicenter, randomized, placebo-controlled trial

Medication abortion through 10 weeks’ gestation, using the FDA-approved regimen of mifepristone and misoprostol, is a highly safe procedure that allows patients flexibility in timing of administration and the privacy of their home. However, some patients may experience significant pain during medication abortion. While current guidelines recommend NSAIDs as needed for pain management during medication abortion, this RCT investigated whether premedication with either oral tramadol or a combination of ibuprofen and metoclopramide affected patient pain scores and/or their use of supplemental pain medicines. Patients in the two control arms were instructed to take one dose of their prophylactic pain medication at time of misoprostol administration and a second dose approximately four hours later. The investigators found that both regimens resulted in lower mean maximum pain scores in comparison with placebo, though neither was clinically significant. Patients who received ibuprofen/metoclopramide were less likely than the placebo or tramadol groups to use additional anesthesia and reported fewer side effects. While these findings did not achieve statistical significance in a group of 563 patients, the authors suggest that these affordable and easily available medicines could be considered for providers looking for prophylactic ways to decrease pain during medication abortion.

5. Population attitudes toward contraceptive methods over time on a social media platform

Social media provides a useful forum for discussion about contraception and reproductive choice, but there are few studies that have examined the relationship between social media and patient preferences. The authors of this study sought to examine the interplay between social media and contraceptive selection. They used “natural language processing” (NLP), in which computers can analyze unstructured or casual text, to review almost 1 million tweets about contraception between 2006 and 2019. Their analysis found an increasing number of tweets about contraception overall, with both positive and negative sentiments. The authors hypothesized that this growing number of social media posts about contraception was secondary to increasing use along with the growing feminist movement. Overall, their findings suggest that social media may play an increasingly important part of patients’ contraceptive preferences, and knowledge about these platforms could allow providers to provide more effective counseling. What to join other providers in the social media conversation about birth control? Check out Bedsider’s Thanks, Birth Control campaign all year long with ##ThxBirthControl.

6. Required examinations and tests before initiating contraception: provider practices from a national cross-sectional survey

According to the CDC’s U.S. Selected Practice Recommendations for Contraceptive Use (US SPR), only two examinations are required for the safe initiation of contraceptive use in a healthy patient: a pelvic examination for IUD placement and a blood pressure check for patients starting combined hormonal contraception. However, past research has demonstrated that many practitioners who provide contraception require additional examinations and tests before providing patients with contraception, which may create barriers to contraceptive use. In this cross-sectional survey of public-sector health centers and office-based physicians providing family planning services in the US, the authors inquired what examinations/tests, if any, providers required before the initiation of several forms of contraception. Among nearly 1,400 providers, the authors found that significant numbers of providers across all specialties required unnecessary testing before providing contraception, including 16-23% requiring pelvic exam before providing non-IUD contraceptive methods, and 78-84% requiring blood pressure measurement before prescribing non-estrogen containing contraception. Providers working in publicly-funded facilities were more likely to practice in accordance with the US SPR. Providers can examine their own practice patterns to ensure accordance with national guidelines to facilitate access and safe contraception provision.

7. Nonindicated pelvic examinations during contraceptive encounters: Prevalence and provider variations

There is evidence that pelvic examinations may lead to pain and health care avoidance when they are performed during clinic visits for patients seeking contraception. As a result, clinical guidance about pelvic exams has evolved, and a routine speculum exam is no longer recommended during a contraceptive encounter unless clinically indicated. The authors of this study found that, based on survey data, many providers continue to perform unindicated pelvic exams, which may alienate patients and lead to unnecessary use of resources. As a result, they created an algorithm to estimate the frequency of unindicated pelvic examinations during contraceptive encounters from 2007-2017. They discovered that approximately 25% of patients received an unindicated pelvic exam during a contraception encounter, and that most of these exams were performed by Ob/Gyn as compared to Family Medicine providers or advance practice clinicians. These findings suggest the need for ongoing provider education on the clinical indications of pelvic exams during contraceptive visits as well as the importance of explicit consent in the exam room.

8. Mifepristone for emergency contraception: Case for recommendation in practice guidelines

Emergency contraception (EC) provides an important contraception option for decreasing the risk of unintended pregnancy after sex, but multiple logistical and institutional barriers may decrease patients’ timely access, especially to more effective EC methods. In this opinion piece, the authors discuss how patients in the US who are not able/willing to have an IUD for EC have only two oral options: oral ulipristal (ella), which is more effective but more costly and requires a prescription, or oral levonorgestrel, a less effective but more easily accessible option. The authors point to mifepristone, another progesterone antagonist, as a likely third candidate for oral EC. They argue that mifepristone has good data showing its safety and efficacy as EC, as well as its affordability. While its use for medical abortion may be contributing to delays in its use as EC, they encourage the World Health Organization to include mifepristone in their global EC guidelines to facilitate increased research and availability.

9. Adolescent Emergency Contraception Usage, Knowledge and Perception

Levonorgestrel EC (Plan B One-Step, Aftera, and other generics) is the only form of EC available for over-the-counter purchase. However, the authors of this study hypothesized that there are ongoing misconceptions about this medication regarding restrictions, age limitations, and access, and that these are particularly pervasive among teenagers. They surveyed adolescent females age 14-21 about their knowledge and experience with levonorgestrel EC. The researchers found that a majority of adolescent females had heard of the pill, though only a minority had actually used it, and less than half were aware that it could be purchased over the counter or that parental consent was not necessary. Overall, these findings indicate a large number of misunderstandings regarding the levonorgestrel emergency contraceptive pill among adolescent females. This is a clear area for ongoing education and counseling, especially among adolescents. To learn more, check out how you can be an EC warrior!

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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