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Research roundup: June 2023 edition

Men’s willingness to use novel birth control, characteristics of patients seeking telehealth medication abortion care, mifepristone as a potential treatment for adenomyosis, and the impact of the pill on adolescent bone health.

by Colleen Denny, MD and Emma Gilmore, MD

published 06/30/23

1. Effect of Mifepristone vs Placebo for Treatment of Adenomyosis With Pain Symptoms

Adenomyosis, or the invasion of endometrial glands into the myometrium of the uterus, is a condition that causes heavy menstrual bleeding, pain, and other complications. Definitive treatment is a hysterectomy, which may not be a feasible option for many patients, particularly those desiring future fertility. The authors of this study noted that mifepristone had been shown to prevent the development of adenomyosis in mice, and they had previously documented its ability to downregulate multiple adenomyosis-supporting genes within uterine tissue. They conducted this double-blind, randomized controlled trial to further evaluate the role of mifepristone for adenomyosis treatment. Patients received either 10mg oral mifepristone or a placebo daily for 12 weeks, and changes in dysmenorrhea intensity were monitored using patient-reported scales. Secondary outcomes included menstrual blood loss and uterine volume. The authors found that mifepristone resulted in statistically significant improvements in all measurements, with dysmenorrhea reductions noted regardless of baseline scores. This preliminary study demonstrates that mifepristone may have a promising future for adenomyosis treatment and should be further explored.

2. Patient Characteristics Associated with Choosing Telehealth vs. In-Clinic Medication Abortion Care

Medication abortion is a safe and effective form of abortion care that currently accounts for more than half of all abortions performed in the US. While medication abortion has traditionally been offered after an in-clinic appointment, research has consistently shown the safety and efficacy of medication abortion using telehealth. In this cross-sectional study, researchers identified nearly 1,700 patients who received a medication abortion from a clinic offering both in-person and telehealth medication abortion to determine which patient sociodemographic characteristics were associated with choosing between the two care models. The authors found that 22.7% of patients overall chose telehealth over in-clinic medication abortion, and that these patients were more likely to be older, non-white, native English speakers, live farther from the clinic, and have had a prior abortion. These findings indicate that telehealth provides an important option for patients seeking medication abortion and may serve different populations of patients who face barriers accessing in-clinic care. Providers seeking to eliminate barriers for their own patient populations can consider incorporating telehealth into their practices to better serve patients’ needs.

3. Awareness of medication abortion among a nationally representative U.S. sample, 2021-2022

While medication abortion represents a safe and effective form of abortion care used by more than half of all patients seeking abortion care, previous population-based research indicates that only a minority of the general population is aware of this form of care. Since the Dobbs decision in June 2022, medication abortion is playing an important role in making abortion care available in more restrictive regions of the country, and public awareness about this option becomes even more important. In this cross-sectional study administered by market research organization Ipsos over two months (December 2021 and January 2022), the authors analyzed whether public knowledge of medication abortion had changed alongside increased attention to greater restrictions on abortion access. Among 7,352 respondents (6,992 assigned female at birth), 64% of those assigned female at birth reported awareness of medication abortion, compared to 57% of those assigned male at birth. Respondents with lower levels of medication abortion awareness were more likely to be Black, foreign-born, under age 18, living in poverty, and have lower levels of completed formal education; those with higher levels of medication abortion awareness were more likely to identify as a gender or sexual minority, have considered abortion, or endorse an opinion about abortion legality. This research indicates that while awareness of medication abortion appears to be increasing in the general population, large gaps in awareness still exist, especially among groups traditionally underserved by the health care system. The authors conclude with a call for efforts to increase awareness about medication abortion with tailored messaging and strategies to reach patient groups that may be less aware.

4. Prioritizing patient experience: Validation of the person-centered contraceptive counseling measure as a performance measure

Patient-centeredness is a fundamental component of contraceptive counseling, as it ensures that the patient’s perspective and goals are at the core of their reproductive health decisions. However, contraceptive counseling and efforts to evaluate it are not standardized, and patients are not typically given an opportunity to provide feedback after receiving counseling. The four-item Person-Centered Contraceptive Care (PCCC) Scale was developed in order to assess self-reported patient-centeredness as a component of contraceptive counseling. For this study, the authors sought to validate the PCCC Scale as part of an application to receive endorsement from the National Quality Forum (NQF), an entity that uses metrics to improve the quality of US health care. By reviewing data across numerous sites and providers, they found that the PCCC Scale is a valid, reliable method for evaluating the patient-centeredness of contraceptive counseling. The PCCC has since been endorsed by the NQF and could be adopted by clinics as a quality measure to improve health equity outcomes. Reproductive health care providers should be aware of the PCCC Scale as a potential component of patient-centered counseling.

5. Men’s willingness to use novel male contraception is linked to gender-equitable attitudes: Results from an exploratory online survey

No novel male contraceptive options are currently on the market, despite many existing studies demonstrating both willingness and interest in using contraception in this population. The authors of this study hypothesized that ongoing biases on gender roles—held by both the pharmaceutical industry and consumers—are preventing male contraception from being adopted and promoted more widely. In order to better explore this question, they conducted an anonymous online survey to assess male willingness to use contraception, along with their attitudes towards gender equality using the validated Gender-Equitable Men Scale (GEMS). They received 2,066 completed surveys from a primarily white, heterosexual, cis-gender cohort. The majority of participants (75%) reported that they would be open to trying novel male contraceptive options, and this willingness was correlated with increasing gender-equitable attitudes as demonstrated by each individual’s GEMS score. Individuals who had experience with abortion also endorsed greater willingness to try novel male contraception. These results further highlight a potential market for novel male contraception and suggest that fostering gender-equitable attitudes may pave the way for greater equality in contraception utilization among pregnancy-capable people if and when male contraception is made available.

6. Levonorgestrel intrauterine system and breast cancer risk: An updated systematic review and meta-analysis of observational studies

Levonorgestrel (LNG) IUDs such as Mirena, Liletta, Kyleena, and Skyla have been increasing in popularity over recent decades and represent a highly effective form of contraception. However, the use of this form of progesterone-containing contraception has an unclear relationship with rates of breast cancer, which may be progesterone-sensitive. In this systematic review and meta-analysis, the authors identified 12 studies and six studies, respectively, to analyze the correlation between LNG IUD use and breast cancer diagnosis; more than 261,000 women were included in the meta-analysis. Separate analyses of both the cohort and case-control studies showed no association between LNG IUD use and breast cancer. While the authors caution that there are inconsistencies across these existing studies, these results generally indicate the safety of LNG IUD use for highly effective contraception without an associated increase in breast cancer risk.

7. Bone impact after two years of low-dose oral contraceptive use during adolescence

Adolescence is an important time for bone mass acquisition, particularly before 18 years of age. It is also a time when many individuals are considering using contraception. There is some data on the effects of hormonal contraception on bone mass development during this time period, but the information is conflicting regarding whether it is detrimental to long-term bone health. For this study, adolescent female participants were divided into three groups: one that did not use combined oral contraceptive pills (COCs), one that used COCs with 20 micrograms of ethinyl estradiol (EE), and one that used COCs with 30 micrograms of EE. Bone mineral density (BMD) was evaluated using DXA scans at the time of inclusion and at 12 and 24 months of study duration, investigators also collected blood samples to evaluate serum biomarkers on bone health. Results indicated that COC users had compromised bone mass acquisition when compared to controls, potentially in a dose-dependent relationship with greater effect in the 30 microgram group. Further study is needed to understand if this change is confirmed in larger groups, and to evaluate the effect of COCs on BMD over an individual’s reproductive lifespan if they start taking them in adolescence.

8. Bacterial Vaginosis and Spontaneous Clearance of Chlamydia trachomatis in the Longitudinal Study of Vaginal Flora

Chlamydia is one of the most common sexually transmitted infections (STIs) in the US and most cases are asymptomatic. When left untreated, chlamydia can result in severe consequences, including pelvic inflammatory disease and infertility. However, there is evidence to suggest that a proportion of individuals spontaneously clear their chlamydia infections, though this phenomenon is not fully understood. Because bacterial vaginosis (BV) has been associated with a possible increase in STI acquisition, the authors of this study questioned whether its presence would affect chlamydia clearance. In order to evaluate this association, they followed a cohort of reproductive-age females in Birmingham, Alabama for one year, performing screenings and exams every three months. The research team found that 48% of index visit chlamydia infections cleared by the next visit, 12 weeks later, consistent with prior studies on this topic. Participants with BV, diagnosed using either Nugent scores or Amsel’s criteria, had a higher likelihood of persistent chlamydia infection. This study contributes to existing knowledge on STI clearance and the vaginal microbiome and reinforces the necessity for BV treatment when it is identified.

9. Long-acting reversible contraception and condom use: A cohort study of female adolescents and young adults in New York City

Long-acting reversible contraception (LARC) options such as contraceptive implants and IUDs are highly effective forms of pregnancy prevention and can be safely used by adolescents and/or nulliparous patients desiring contraception. However, these methods, as well as all other non-barrier methods, do not protect against STIs. In this longitudinal study among sexually active females aged 13-25 years old, the authors analyzed whether LARC use versus non-LARC hormonal contraception (pill, patch, ring, or injection) use was associated with decreased condom use. Among 1,116 participants reporting either LARC or non-LARC hormonal contraception use, condom use at last sexual encounter was overall significantly lower among baseline LARC users (23.5%) compared to non-LARC hormonal contraception users (37.5%), but that finding was driven by respondents 13-18 years old. Respondents who previously used condoms but initiated LARC during the study were also more likely to discontinue condom use than those initiating non-LARC methods. The number of sexual partners, a risk factor for STI acquisition, was not associated with dual contraception use for either group. This research is an important reminder for providers caring for sexually active adolescents to assess risk for STIs acquisition and counsel on strategies to prevent STIs, including younger LARC users.

10. Clinical outcomes of intrauterine device insertions by newly trained providers: The ECHO trial experience

IUDs are a popular and safe form of contraception that can be safely used by most people. However, IUD initiation requires a provider trained in IUD placement, and IUD placement is more likely to be successful with a more experienced provider. In this secondary analysis of the ECHO trial, which randomized patients to copper IUD, contraceptive implant use, or DPMA injection, the authors analyzed the failure and complication rates of IUDs placed by providers newly trained in IUD placement. Approximately 5% of initial IUD insertion attempts were unsuccessful. Perforation rates were reported at 0.27% and were more common among patients who were less than three months postpartum and breastfeeding. Complete or partial IUD expulsion rates were higher than those typically reported in the literature, with 10.3% at 6 months, 13.6% at 12 months, and 17% at 18 months. The authors conclude that providers newly trained in IUD insertion can generally safely provide IUDs, and that structured training and ongoing clinical support allows IUD provision even in resource-constrained settings.

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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