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Research roundup: August 2024 edition

U.S. MEC and U.S. SPR, standard dosing of UPA EC for people of all body sizes, birth control information on TikTok, and safety of medication abortion without screening ultrasound.

by Colleen Denny, MD and Emma Gilmore, MD

published 08/30/24

1. U.S. Medical Eligibility Criteria for Contraceptive Use, 2024 (U.S. MEC)

This updated version of the US Medical Eligibility Criteria for Contraceptive Use (US MEC) replaces the 2016 version and is adapted from guidance from the World Health Organization (WHO). The US MEC provides recommendations for providers regarding the safe use of contraception for patients with specific characteristics and medical conditions. Providers can reference this information based on either the contraceptive method or the medical condition itself. In this new version, the guidelines have been revised regarding contraceptive use for individuals with chronic kidney disease, along with numerous other medical conditions including obesity, recent surgery, and high risk for HIV acquisition. The list of contraceptives has also been expanded to include updated or new dosing options along with previously absent methods such as vaginal pH modulator. This updated guidance is high yield for anyone providing reproductive health care, and it can be downloaded to a computer, printed out as a reference chart, or used through an app.

2. U.S. Selected Practice Recommendations for Contraceptive Use, 2024

Adapted from guidance created by the World Health Organization (WHO), the US Selected Practice Recommendations for Contraceptive Use (US SPR) is a companion document for the US. The US SPR addresses the initiation and use of contraception, and provides specific information on the initiation and use of contraceptive methods in scenarios such as amenorrhea, postpartum, and post-abortion. This updated document replaces the earlier version from 2016. Specific updates include pain management during placement of IUDs, bleeding irregularities during implant use, testosterone use and risk of pregnancy, and availability of self-administration of the shot. Providers should use this document as a reference when providing patient-centered contraception counseling.

3. Advancing Pain Management Protocols for Intrauterine Device Insertion: Integrating Evidence-Based Strategies Into Clinical Practice

The efficacy of IUDs is well-established, but patient anxiety about pain, side effects, and adverse events is well documented. The authors of this study performed a literature review in order to assemble evidence on minimizing pain and anxiety during IUD placement and identified 14 relevant studies. These studies confirmed that anxiety and fear, particularly related to a prior negative experience related to a pelvic exam, are the biggest barriers to IUD use. Lidocaine, NSAIDs, misoprostol, and tramadol are some pharmacologic approaches that have been shown to help with discomfort during IUD placement. However, while there are numerous studies on pharmacologic approaches to pain control, there is a need for more study on non-pharmacologic management strategies. The authors also recommend improved patient education about IUD placement in order to dispel misconceptions and help patients with anxiety.

4. Patient Preferences for Immediate Compared With Delayed Postpartum Intrauterine Device Placement

If an individual desires an IUD for postpartum contraception, they are typically provided with a choice between an immediate postpartum IUD—placed right after delivery—and a delayed postpartum IUD, which is placed at their postpartum visit. While both options are safe and effective, immediate postpartum IUDs have higher rates of complications such as IUD expulsion or malpositioning. However, they have higher real-world effectiveness at one year after delivery, due to the barriers that many individuals experience regarding their postpartum visit. In other words, if a patient prefers a delayed IUD placement, but is unable to attend their appointment due to personal or structural barriers, their choice is less effective at preventing pregnancy than an immediate postpartum IUD. For this study, the authors surveyed non-pregnant, pregnancy-capable individuals about their hypothetical preferences regarding the timing of postpartum IUD placement. While there were some differing results with regard to insurance type, overall most patients preferred delayed postpartum IUD placement, and were concerned about risks such as malpositioning. These results further support existing recommendations to provide patient-centered counseling regarding postpartum contraception, regardless of patient characteristics.

5. Double dosing ulipristal acetate emergency contraception for individuals with obesity: a randomised crossover trial

Emergency contraception (EC) is an important option for individuals seeking to prevent pregnancy after unprotected intercourse. Levonorgestrel EC, popularly known as Plan B, exhibits sharply decreased efficacy in patients whose body mass index (BMI) exceeds 30 mg/kg2. Limited data suggests that ulipristal acetate (UPA), brand name ella, demonstrates similarly decreased efficacy in individuals with BMI >30 mg/kg2 or weight >80kg, but this data has not been fully explored. The authors of this study performed a randomized controlled trial in which they compared 30mg of UPA to 60mg in patients with BMI >30 mg/kg2 or weight >80kg, hypothesizing that the double dose would have increased efficacy. Subjects served as their own comparisons, and a group of individuals with BMI <25 mg/kg2served as controls. Subjects were evaluated for ovulation, defined as follicle rupture, along with hormone levels and pharmacokinetic parameters. When ulipristal acetate dosing occurred before LH surge—which is necessary for it to work regardless of patient BMI—subjects with BMI >30 mg/kg2 experienced a 5-day delay in ovulation regardless of dosing. Therefore, the authors concluded that dose adjustments do not need to be performed based on BMI or weight. These results serve to reinforce the utility of UPA and reassure patients and providers who are concerned about decreased efficacy due to BMI or weight.

6. An analysis of oral contraceptive related videos on TikTok

Social media platforms, especially video-sharing platforms such as TikTok, have become a common source of health information, especially adolescents and young adults. The design of these platforms allows all users to create and publish content directly to other users, and the quality and reliability of health information available on these platforms may vary, especially reproductive health and contraception information. In this infodemiological study, the authors screened 1,000 TikTok videos available regarding oral contraception to determine the quality/accuracy of health information, the source of the video, and engagement metrics such as likes and comments. Among 574 videos, the authors found that most videos were either informational (63%) or patient testimonials/seeking advice (29%); the majority (65%) were published by non-health care professionals. Educational videos generally and videos from health care professionals were more likely to score higher on indexes of quality and reliability of healthcare information, but videos from non-healthcare providers and testimonial videos were more likely to have higher viewer engagement overall. This study highlights the increasing use of social media as a source of health care information for many patients, as well as the need for providers to consider the ubiquity of low-quality health care information published on these platforms that may affect patients’ contraception choices.

7. Comparing Transcervical Balloon with Osmotic Dilators for Cervical Preparation Prior to Procedural Abortion: a Non-Inferiority Randomized Trial

Cervical preparation before second-trimester procedural abortion increases the safety of this procedure. Different mechanical agents and medications may be used for cervical preparation, as no single protocol has been shown to be most effective, and differences in supply availability may affect individual institutions’ choices. The Foley transcervical balloon catheter can be used to mechanically dilate the cervix and represents a possible safe and inexpensive alternative to mechanical dilation with laminaria. In this randomized noninferiority trial, the authors recruited 32 patients undergoing D&E between 18 and 24 weeks’ gestational duration. All patients received mifepristone before D&E and same-day misoprostol, as well as either Foley balloon or Dilapan-S laminaria. In their analyses, the authors found that procedure time, cervical preparation insertion time, maximum pain during insertion, maximum pain overnight, complication rates, and patient satisfaction was similar between the two groups. Patients with Dilapan-S were more likely to have cervical dilation > 2cm and less likely to require mechanical dilation during the procedure than the Foley balloon group, and maximum post-insertion pain was higher in the Dilapan-S group. While the authors report that their primary outcome of procedure time did not meet non-inferiority criteria, differences overall appeared to be clinically negligible. Given the difference is cost for these options, Foley balloons may represent an adequate low-cost alternative for cervical preparation before D&E.

8. Clinical and service delivery outcomes following medication abortion provided with or without pre-treatment ultrasound or pelvic examination: an updated comparative analysis

Medication abortion using mifepristone and misoprostol is a highly safe and effective form of abortion and is now used for the majority of abortions happening in the United States. In recent years, especially starting in the COVID-19 pandemic, providers have begun offering medication abortion for patients without prior in-person assessment, including ultrasound for gestational dating or blood tests. In this comparative analysis of previously collecting data from telehealth medication abortion, the authors analyzed outcomes for patients who had no prior imaging/testing before their medication abortions (“No-Test group”) versus patients who did (“Test group”), and further broke these patients into time periods, either March through mid-September 2020 or mid-September 2020 through September 2021. Among approximately 1,000 patients, the authors found that patients in the No-Test group did not have an increased risk of serious adverse events or with failure to terminate an ongoing pregnancy. They noted that while patients in the No-Test group in the earlier time period were more likely to require a procedure for abortion completion or to have an unplanned clinical visit for abortion care reasons, this risk did not persist over time and patients in the No-Test group in the later time period had outcomes similar or better than the Test group. Patients in the No-Test group were also overall more likely to receive care within a week than the Test group. These findings continue to add to research showing the safety and efficacy of telehealth medication abortion for appropriate candidates, and suggest that non-urgent visits during telehealth medication abortion become less common as patients and providers become more familiar with the process.

9. Self-Determination of Eligibility for Medication Abortion Without Ultrasonography Using a History-Based Tool

Telemedicine for medication abortion has become an increasingly popular means of accessing abortion care, with 8% of all abortions now provided through virtual-only clinics. In the absence of in-person testing or ultrasound, history-based screening must be used to determine who is an appropriate candidate for telemedicine medication abortion by attempting to identify patients of gestational duration beyond 11-12 weeks and/or at higher risk of ectopic pregnancy. In this prospective study of more than 700 patients seeking in-person abortion care, the authors analyzed the performance of LMP-SURE, a screening questionnaire for patients seeking telehealth medication abortion to determine whether patients would have been correctly screened as appropriate candidates to forego ultrasound assessment. The authors found 65% of patients were deemed appropriate candidates for no-ultrasound medication abortion with LMP-SURE, as compared to 91% of patients eventually found to be candidates for medication abortion after ultrasound. LMP-SURE had a sensitivity of 83% and specificity of 70%. The percent of false-negatives (patients who would have been deemed appropriate candidates for telehealth medication abortion when their in-person ultrasound showed them to be inappropriate) was 1.5%, and only 0.8% if a 77 day cut-off was used. Ectopic pregnancies were rare in the patient group, and none were screened as appropriate to proceed without ultrasound. The authors discuss that this type of brief, conservative screening protocol can be used by providers to minimize the chance of unsafe use of telemedicine medication abortion while also allowing the majority of appropriate patients to proceed more quickly with care.

10. State Abortion Policy and Moral Distress Among Clinicians Providing Abortion After the Dobbs Decision

The concept of moral distress is used to describe when individuals feel powerless to do what they think is right, and can occur when health care providers are either forced to provide care they feel is morally wrong, or cannot provide care when they feel it is necessary. Moral distress can lead to burnout, psychological distress, and low self-reported well-being. With an increasing number of state-level bans on abortion provision, many reproductive health care providers are prevented from providing appropriate care for their patients. In this survey study, the authors assessed feelings of moral distress among more than 300 abortion providers across different US states, including physicians, advanced practice clinicians, and nurses. They found that indicators of moral distress were twice as high among physicians practicing in ban states, as well as providers who had stopped providing abortion care or were practicing in states with the greatest decline in abortion volume since the Dobbs decision. The authors discuss that increased moral distress has the potential to increase burnout and drive reproductive health care providers out of the workforce and argue for the need for better state- and federal-level protection for abortion 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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