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Research roundup: May 2024 edition

Patient characteristics of IUD placement under sedation, two studies on EC efficacy, substance use and anxiety among patients seeking an abortion, and genital herpes prevalence.

by Colleen Denny, MD and Emma Gilmore, MD

published 05/31/24

1. Use of serum evaluation of contraceptive and ovarian hormones to assess reduced risk of pregnancy among women presenting for emergency contraception in a multicenter clinical trial

Oral emergency contraception (EC) with levonorgestrel or ulipristal acetate effectively prevents pregnancy when taken in the days after sex by delaying ovulation. However, these methods offer little benefit for patients who have already ovulated. Likewise, patients who are already using a form of birth control that prevents ovulation may not need to seek out additional contraception in the form of EC. Both of these factors can skew data that report on the efficacy of EC making it difficult to accurately counsel patients or interpret the efficacy of EC. In this secondary analysis from a randomized controlled trial of 532 patients seeking oral EC, the authors assessed serum levels of endogenous hormones and contraceptive steroids to determine whether patients showed evidence of previous ovulation and/or sufficiently recent contraception use. They determined that more than a third (37.3%) of patients showed evidence of recent ovulation, and another 23% had elevated serum levels of exogenous contraceptive steroids, with 10% above the minimum level though to provide sufficient contraceptive efficacy. The authors conclude that a high percentage of patients seeking EC may either not be at risk of pregnancy or would not have benefitted from EC given cycle timing, and counsel that these findings should be used for a more nuanced interpretation of pregnancy rates with future EC trials using noninferiority designs or historical controls.

2. Emergency contraception for individuals weighing 80kg or greater: a randomized trial of 30 mg ulipristal acetate and 1.5 mg or 3.0 mg levonorgestrel

While oral EC with levonorgestrel (LNG) or ulipristal acetate provides an important option for pregnancy prevention, previous research suggests that LNG EC declines in efficacy for patients who weigh more than 70kg and appears to have no efficacy for those over 80kg. In this randomized controlled trial of approximately 500 patients over 80kg with recent unprotected intercourse who were seeking oral EC, the authors analyzed pregnancy rates for three oral EC options: 1.5mg LNG, 3mg LNG, or 30mg ulipristal acetate. The authors found no difference in pregnancy rates among the three groups in an interim analysis but noted that recruitment was slow and pregnancy rates were low, leading to the early discontinuation of the study for futility. They conclude that they are unable to confirm differences in oral EC efficacy among patients weighing more than 80kg and highlight the difficulty of recruitment for EC research generally.

3. IUD Insertion Under Conscious Sedation: Patient Characteristics with Clinical Decisions

IUDs are a highly effective reversible form of contraception and can be safely used by virtually all patient populations, including nulliparous patients, patients who have not had vaginal sex, and adolescent patients. However, fear of discomfort during IUD insertion may be a significant deterrent, especially among young patients. In this retrospective cohort study at a site offering both light sedation with nitrous oxide gas or moderate sedation with IV fentanyl and midazolam, the authors analyzed what adolescent patient factors influenced the choice of sedation level. Among 69 IUD insertion attempts during the study period, 93% of which were successful, the authors found that previous sexual activity was associated with a greater likelihood of choosing light sedation but was not associated with greater IUD insertion success rates. Age, history of sexual assault, tampon use, and gender identity were not associated with either sedation choice or likelihood of failed IUD insertion. The authors conclude that these findings can help providers focus their sexual history taking and counsel patients about sedation choices for IUD placement.

4. The impact of embedment of the side arms of 52 mg levonorgestrel-intrauterine device on bleeding and pain: A prospective cohort study

Levonorgestrel intrauterine devices (LNG-IUDs) are effective and safe, but patients report irregular spotting and cramping with relative frequency. When these complaints arise, health care providers often perform an ultrasound to assess the position of the LNG-IUD, but the information is lacking on the ways that the IUD position impacts patient symptoms. Although ultrasound is not a failsafe imaging method for IUDs, it is the only way to assess their position without hysteroscopy. This study was conducted using 3D transvaginal ultrasound to assess whether myometrial embedment of IUD arms is associated with symptoms such as pain and bleeding. This was a prospective observational cohort study conducted among 220 patients in the Netherlands. The authors found that unfavorable pain and bleeding symptoms were not associated with apparent myometrial embedment of the IUD arms on 3D pelvic ultrasound. While further research is needed in this understudied area, these results suggest that IUD position may not be the best explanation for adverse symptoms such as pain and bleeding.

5. Permanent and Long-Acting Reversible Contraception volumes at a multi-hospital system in Ohio before and after Dobbs

The Supreme Court’s Dobbs decision in June of 2022 eliminated federal protection for abortion access and allowed many states to enact abortion restrictions or outright bans that require patients in these states with undesired pregnancies to either travel for abortion care or self-manage their abortion. These limits to abortion access have the potential to impact patients’ contraception choices. In this retrospective cohort study in a multicenter hospital system, the authors analyzed changes in uptake for both permanent sterilization procedures and long-acting reversible contraception (LARC) use in the six months before and after the Dobbs decision and Ohio’s subsequent ban on abortion after the detection of cardiac activity. They identified a total of 4,247 combined permanent contraception procedures (both tubal ligation and vasectomy) and LARC initiations in the six months before Dobbs, which increased more than 15% in the six months after the Dobbs decision. Post-Dobbs, patients seeking LARC or permanent contraception were younger and more likely to be single. The authors conclude that federal and state-level policy changes and restrictions have the potential to change patients’ contraception choices, potentially through fear of limited abortion access, and may limit patients’ ability to make empowered choices regarding contraception.

6. Provision of Medications for Self-Managed Abortion Before and After the Dobbs v Jackson Women’s Health Organization Decision

Since June 2022, abortion access has decreased throughout the US. In the six months after the Dobbs decision, it is estimated that more than 32,000 fewer abortions were provided in the traditional health care setting. However, as formal abortion provision has been limited, more attention has been given to alternative methods of abortion provision, specifically self-managed abortion. Self-managed abortion can take numerous forms but is increasingly undertaken using evidence-based medication regimens obtained through online sources. The authors of this study sought to understand how many people turned to methods of self-managed abortion in the six months after the Dobbs decision. They conducted a broad landscape review, reviewing numerous available resources, including internet searches, interviews with advocates, and online vendors. Using this cross-sectional information, they estimated that more than 26,000 additional medication abortions were provided outside of the formal US healthcare system between July 1 and December 31, 2022. These results highlight the prevalence of self-managed abortion care, particularly in a landscape of limited access.

7. Interest in and Support for Alternative Models of Medication Abortion Provision Among Patients Seeking Abortion in the United States

Medication abortion, which is most effective when administered as a combination of mifepristone and misoprostol, is the most frequently utilized form of abortion in the US. Its safety, acceptability, and efficacy are well-documented, but numerous legal and logistical burdens have led to restrictions on access. Alternative delivery models of medication abortion, through methods such as online, advanced provision, and over-the-counter services, are becoming increasingly popular ways to improve access. However, little is known about patient perceptions of these forms of care delivery. For this study, the authors performed a secondary analysis of survey data to explore patient perceptions of alternative models of medication abortion provision. More than 1,700 responses were analyzed. Participants were interested in all methods, especially advanced provision, though there was some variation in response according to sociodemographic characteristics. These results provide support for all alternative methods of medication abortion provision but suggest that providers should maintain awareness of differing needs among diverse patient groups.

8. Substance Use and Anxiety About Pain Among Patients Seeking Abortion Services

Millions of pregnancy-capable individuals in the US report the use of opioids, marijuana, and other substances. Limited research suggests that people who use these substances may have heightened sensitivity to pain, but little is known about the way that substance use and pain-related anxiety intersect with abortion care. The authors of this study performed a prospective, cross-sectional, anonymous survey of more than two hundred patients to assess the way that recent use of opioids, marijuana, and cannabidiol (also known as CBD) were related to anxiety about pain during abortion. Almost half of the study participants reported recent use of marijuana, but rates of use of other substances were much less frequent. Though only used by a small subset of patients, recent opioid use was associated with significantly greater anxiety about abortion-related pain. However, recent marijuana and CBD use did not result in significant differences. These results suggest a need for more research in this area which could help abortion providers more effectively address patient concerns about pain for patients who recently used substances.

9. Reproductive healthcare in adolescents with autism and other developmental disabilities

Individuals with developmental disabilities, including autism, are known to have decreased access to reproductive health care. Inadequate care in areas such as contraception, cervical cancer screening, or menstrual assessments may lead to adverse outcomes for this population. However, little is known about the way that adolescents with developmental disabilities interact with reproductive health care resources during the key moment in which they are transitioning to adulthood. The authors of this study used the Kaiser healthcare system to analyze adolescents with autism and other developmental disabilities and compare them to a control group of typically developing adolescents. They specifically sought information on access to obstetrical and gynecologic care, the prevalence of menstrual conditions, and prescriptions for birth control. Their results indicated that adolescents with autism and other developmental disabilities were more likely to report benign gynecologic conditions such as polycystic ovarian syndrome or menstrual abnormalities than their typically developed peers; however, they were also less likely to see a reproductive health care provider or receive a prescription for birth control. This study identified a gap in access for this vulnerable population, suggesting a need for increased provider education and targeted programs.

10. Prevalence of Diagnosed Genital Herpes and Antiviral Treatment in the United States

Genital herpes is a common viral STI among patients in the US and can significantly impact patients’ quality of life. Patients may have variable symptom burdens over the lifelong course of the infection, including those who are entirely asymptomatic, but there is less available epidemiologic data about the number of symptomatic patients seeking care. In this observation cohort study, the authors used claims data from December 2017 through December 2021 to identify diagnosed cases of genital herpes and analyze their medication use. Among 60,000-80,000 genital herpes claims cases identified each year of the study, the authors noted that 75% of the patients were female, that higher prevalence were noted among the 25-29yo age group (497-582 among 100,000 person-years), and those with a history of HIV infection (1608-2080 among 100,000 person-years). Approximately two-thirds of patients with genital herpes received antiviral medications, with the majority (80%) receiving episodic therapy rather than suppressive therapy. The authors conclude that genital HSV remains common in the US, and that young, female, and/or immunocompromised patients are more likely to seek care for this condition.

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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