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Research roundup: August 2023 edition

COX-2 inhibitor demonstrates potential in increasing efficacy of OTC LNG-EC pills; updated systematic review and meta-analysis supporting the effectiveness and safety of misoprostol-alone for medication abortion; support needs of adolescents and young adult abortion seekers; and more!

by Colleen Denny, MD and Emma Gilmore, MD

published 08/31/23

1. Early pregnancy loss medical management in clinical practice

Early pregnancy loss (EPL) is a common occurrence among reproductive-aged patients, affecting an estimated 10-20% of all clinically recognized pregnancies. If patients opt for medical management of EPL, studies have shown that a combination of mifepristone and subsequent misoprostol is highly effective and safe. However, management and individual patient outcomes may vary in clinical practice outside of the research setting. In this retrospective cohort study, the authors reviewed records for 90 patients who received medical management of EPL after a clinic adopted a mifepristone/misoprostol regimen. They found that 89.4% of patients overall had successful EPL management without the need for uterine aspiration and that adverse events were overall rare. This study suggests that medical management with mifepristone and misoprostol is a safe and effective treatment for EPL in a real-world clinical setting and can be safely offered to patients who desire this option.

2. Effectiveness and Safety of Misoprostol-Only for First-Trimester Medication Abortion: An Updated Systematic Review and Meta-analysis

In 2019, the authors of this paper published a review on the effectiveness and safety of misoprostol-only regimens for first-trimester medication abortion through 91 days’ gestational age, which included studies published through November 2017. Here, they update this review by evaluating studies published through December 2022. They were able to evaluate a total of 66 study groups that encompassed more than 16,000 patients. Across all groups, the efficacy of misoprostol-only regimens is an estimated 85% and misoprostol-only regimens were found to be safe for patients. However, efficacy rates increased when patients administered 800mcg of misoprostol up to four times, either vaginally, buccally, or sublingually. While medication abortion with a regimen of mifepristone and misoprostol remains the most effective and should be used whenever possible, this updated systematic review and meta-analysis can be used to advise clinical teams who may need updated guidance based on possible changes in mifepristone availability or for those who do not have access to mifepristone.

3. Medication abortion via digital health in the United States: a systematic scoping review

After it became more commonly recognized during the COVID-19 pandemic, digital health, including telehealth, has been increasingly utilized for health care delivery and integrated into the standard of care. Telehealth abortion care has been shown to have similar effectiveness to in-person services and can provide access for patients who otherwise would not have local access to reproductive health care. Increasing access via telehealth is particularly important for individuals seeking abortion care as many states reduce or remove local access entirely. The authors of this scoping review evaluated 33 studies on telehealth abortion care delivery. Their goal was to identify predominant themes to better understand the experiences of both abortion seekers and providers, including effectiveness, acceptability, and general perspectives. They found that effectiveness and acceptability were similar among all forms of abortion care delivery. Preferences were not universal: while many patients preferred and appreciated the ease of telehealth, some preferred in-person visits. Telehealth was often preferable due to location, budget, or other logistical issues. Overall, this study reaffirms the effectiveness of and satisfaction with telehealth abortion care as well as its role in increasing access to abortion care.

4. "Time and money and support": Adolescents and Young Adults' Perceived Social and Logistical Support Needs for Safe Abortion Care

To access abortion, adolescents face numerous, well-established barriers, including financial constraints, issues with privacy and judicial bypass, and later recognition of pregnancy. As abortion restrictions expand around the United States after Dobbs v. Jackson in June 2022, barriers for all patients have increased. However, due to their already vulnerable position, adolescents and other young pregnancy-capable people are disproportionately affected by new restrictions. The authors of this paper conducted a text survey study to assess social and logistical needs for safe abortion care, as described by adolescents and young adults. This specific article focuses on responses to questions on support networks and travel out of state. The authors received 638 responses to their survey, for a response rate of 78%. Adolescents most often identified parents and friends as their support people and cited money, transportation, and lodging as barriers to seeking abortion care in other states. Based on these results, adolescents without stable social networks or access to financial support may find that it is even harder for them to access abortion care. Awareness of these barriers can help providers counsel adolescent and young adult patients seeking abortion care and identify areas for additional support or attention.

5. Oral emergency contraception with levonorgestrel plus piroxicam: a randomised double-blind placebo-controlled trial

In the United States, the only over-the-counter (OTC) form of emergency contraception (EC) is a single 1.5mg dose of oral levonorgestrel (LNG) EC (Plan B and generics). LNG EC is a safe and effective option when used up to 72 hours after intercourse and while LNG EC can be taken up to 125 hours after intercourse, its effectiveness decreases over time and significantly after 72 hours. Additionally, LNG EC is not effective if taken after ovulation, and patients using LNG EC still have a 1-3% risk of pregnancy. Piroxicam, an oral COX-inhibitor, has the potential to further decrease the risk of pregnancy given its known effects on human ovulation. In this randomized placebo-controlled trial, researchers recruited 860 patients seeking LNG EC and randomized them to receive either LNG EC plus 40mg of piroxicam or LNG EC plus a placebo. In their analysis, the authors found that pregnancy rates were significantly lower in the intervention group, with pregnancy rates of 0.2% compared to 1.7% in the control group. No differences in adverse events were noted between the groups. While more research is needed, this study shows a potential opportunity to improve the efficacy of EC for patients who prefer an oral option.

6. Comparison of interpersonal quality of contraceptive counseling delivered via telehealth versus in-person

Counseling about and provision of contraception is an important component of reproductive health care. While this historically occurred during in-person clinic visits, the COVID-19 pandemic pushed providers to rapidly adopt telehealth for many aspects of care, including contraception counseling. As the COVID-19 public health emergency ends, providers and patients may have lingering questions about the efficacy and patient satisfaction of telehealth contraceptive counseling. In this cross-sectional survey of approximately 300 patients seeking contraception at a Title X-funded clinic, the researchers queried patients on their satisfaction with either in-person or telehealth contraception counseling. The authors found no significant difference in patient satisfaction between the in-person and telehealth groups, which were both found to be high quality by patients. They did note that patients choosing telehealth were slightly less likely to attend a subsequent in-person visit and that telehealth patients were significantly more likely to choose phone (70%) over video (30%) telehealth. The authors concluded that patients perceive that telehealth provides equally high-quality contraception counseling as in-person visits and note that patients’ preference for phone over video visits may represent an important option for patients who do not have access to video-based technology.

7.A randomized trial comparing the 52-mg levonorgestrel system to combination oral contraceptives for treatment of heavy menstrual bleeding

Heavy menstrual bleeding (HMB) affects about a third of all people with uteruses during their lifetimes and can have a significant negative impact on physical and mental health as well as quality of life. Both levonorgestrel IUDs and combined oral contraceptive pills (COCs) are commonly prescribed to help patients manage HMB, but few high-quality studies compare their relative effectiveness. In this randomized trial, researchers recruited 62 patients with HMB without an anatomic cause, randomized them to either 52-mg levonorgestrel IUD or cyclic COCs, and followed their bleeding-related quality of life scores for a total of 12 months. Of the 47 patients who completed the protocol, bleeding-related quality of life scores improved significantly for both groups starting as soon as six weeks and lasting through 12 months. While the IUD arm participants reported greater improvement in scores at six months, the improvement was not significantly different from COC users among the per-protocol patients at 12 months. These findings, while from a relatively small study, suggest that providers should feel comfortable offering either levonorgestrel IUDs or COCs to patients who desire medical management of HMB.

8. Combined oral contraceptive pill for primary dysmenorrhoea

Primary dysmenorrhea, defined as painful menstrual cramps without known pelvic pathology, is a common source of recurrent pain for menstruating patients and can significantly affect quality of life. While combined oral contraceptive pills (COCs) are commonly prescribed to help patients with dysmenorrhea, few systematic reviews describe the potential benefits and harms of this practice. In this Cochrane review, the authors identified 21 randomized controlled trials of nearly 4,000 patients examining the use of COCs for primary dysmenorrhea. In their analysis, the authors concluded there is good evidence that COCs improve dysmenorrhea-related pain compared to placebo treatment and that continuous COC usage probably improves pain more than cyclic usage. There was insufficient data on COCs versus NSAIDs for managing dysmenorrhea, and COCs were more likely to be associated with side effects such as nausea, headaches, and irregular bleeding. This review suggests that COCs, especially when taken continuously, are an effective option for patients who desire medical management of primary dysmenorrhea.

9. Long-acting Reversible Contraception in Gender-Diverse Adolescents and Young Adults: Outcomes from a Multisite Collaborative

Long-acting reversible contraception (LARC), like intrauterine devices (IUDs) and implants, have long been well-established as a safe and effective birth control option for adolescents and young adults. However, less is known about these methods for gender-diverse adolescents, though they are a growing proportion of young patients seeking reproductive health care. To better understand the experiences of gender-diverse adolescents regarding these methods, the authors of this study conducted a secondary analysis of prospective data that had been collected from four adolescent medicine clinics. They were able to review data for 63 patients who had successful or attempted LARC insertions, and found that gender-diverse young people chose these methods for both birth control and menstrual control. While some studies have reported difficulty in IUD placement in gender-diverse adolescents, this study found that the majority of IUD placements were successful in this population. Overall, both IUDs and implants were well-tolerated for the adolescents and young adults studied here. Although this was a small sample size and the topic necessitates further study, these results provide encouraging evidence that can inform counseling and practice.

10. A Pilot Study of Adolescent and Young Adult Experience with Subcutaneous Depot Medroxyprogesterone Acetate

Depot medroxyprogesterone acetate (DMPA, brand name Depo Provera), is an injectable progestin that can be used in numerous ways, including contraception and menstrual suppression. While it is typically administered via intramuscular injection, subcutaneous (SQ) DMPA has gained popularity since the COVID-19 pandemic because it can be injected at home by the user without the necessity of a clinic visit. This study focuses on the experiences of adolescents and young adults who chose DMPA-SQ between 2019 and 2021. Thirty-four patients filled out a 20-item survey that assessed their feelings regarding adherence, satisfaction, preferences, feasibility of self-administration and prescription, and continuation. Overall, respondents noted high levels of feasibility and satisfaction with DMPA-SQ, though a minority of patients (41.4%) were self-injecting the medication, with the remainder receiving injections from a family member or in a clinic. Twenty-one percent of respondents reported missing their injection window, suggesting that there may be opportunities for additional counseling or education in this age group. Overall, these results reinforce the utility of self-controlled contraception options for young patients and encourage further study. Check out this Provider’s Guide with everything you need to know about DMPA-SQ in your practice.

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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