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Research roundup: December 2024 edition

Clinical trial data on a new IUD, clinical guidance on self-managed abortion, the impact of the ACA on reproductive health, and CDC’s abortion surveillance data.

by Colleen Denny, MD and Emma Gilmore, MD

published 12/31/24

1. Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device

Patients seeking hormone-free long-acting reversible contraception in the United States currently only have a single option, the TCu380A IUD (brand name Paragard) approved for the US market 40 years ago. This research presents phase-3 data on safety, efficacy, and tolerability outcomes for the investigational Cu 175 mm2, a novel three-year copper IUD with a thinner loaded inserter diameter (3.7mm vs 4.75mm with TCu380A IUD inserter). The phase 3 study enrolled 1,620 patients with the potential for pregnancy, with 1,483 participants ≤35 years of age. The authors found that 98.8% of IUD placement attempts were successful on the first or second attempt, with a 79% continuation rate at one year and a 49% continuation rate after three years. The one-year Pearl Index was 0.94, with pregnancy rates at 1.26% at one year and 2.47% at three years. The most common adverse events were heavy menstrual bleeding and/or dysmenorrhea, reported by 88% of participants in the first three months of use but decreased to 17.7% in year three; 22% of patients discontinued study participation due to an adverse event; 0.4% of participants had ectopic pregnancies. The authors conclude that contraceptive efficacy rates and ectopic pregnancy rates are similar to those of the TCu380A IUD, and that rates of bleeding and cramping reported seem also similar overall. This data demonstrates the potential of the three-year copper IUD to safely add to patients’ options for long-acting reversible contraception.

2. Patient and OBGYN Perspectives on Considering Long-Acting Reversible Contraception for Postpartum Patients Who Desire Permanent Contraception

Long-acting reversible contraception (LARC), such as IUDs and the contraceptive implant, and permanent contraception, through tubal ligation or bilateral salpingectomy, have similar efficacy in preventing pregnancy and both can contraceptive implants, and permanent contraception, through tubal ligation or bilateral salpingectomy, have similar efficacy in preventing pregnancy, and both can be safely initiated during be safely initiated the postpartum period. Patients who have completed childbearing may choose any of these methods, but patients’ preferences and clinicians’ priorities may not align in discussing these options. In this semi-structured qualitative interview study, the authors recruited 81 recently postpartum patients who had expressed a desire for permanent sterilization in their prenatal care as well as 67 of their delivering OB-GYN physicians. The authors identified four themes across these interviews: 1) reversibility versus permanence of contraception, 2) menstrual suppression, 3) cancer risk reduction, and 4) avoidance of hormones or foreign bodies. They found that while many OB-GYN prioritized reversibility and menstrual suppression, patients were more likely to discuss the appeal of permanence, avoiding menstrual suppression, cancer prevention, lack of foreign body, and avoiding repeat negative experiences with LARC. The authors discuss that patients seeking permanent contraception may have contraceptive values and preferences not adequately addressed by LARC methods. Clinicians should make sure they center the preferences of patients during counseling to avoid imparting their own biases.

3. Differential bone calcium retention with the use of oral versus vaginal hormonal contraception: A randomized trial using calcium-41 radiotracer

There is conflicting data regarding the effect of hormonal contraception on bone health and existing studies have not found an ideal way to analyze this relationship. The authors of this study, seeking more accurate information, used a “radiotracer”, or radioactive calcium atoms, to evaluate the behavior of bones in patients who used hormonal contraception. After extensive screening, participants received radioactive calcium through intravenous fluid, which then equilibrated within their bones for 100 days. Next, they were monitored during un-medicated menstrual cycles, and then they took hormonal contraception, either combined oral contraceptive pills (COCs) or the vaginal ring. If the contraception changed the participants’ bone composition, this would be reflected through a detectable change in the presence of radioactive calcium in their urine. Because subjects were evaluated both with and without contraception, they served as their own controls. Eight participants completed the study—three COC users and five using the ring—reflected adequate power to detect a difference in calcium excretion. The authors found that COCs improved bone calcium retention, while the ring did not make a difference. While the long term clinical significance of these results is unknown, they do signal a need for additional research on this topic.

4. Effects of the Affordable Care Act on Contraception, Pregnancy, and Pregnancy Termination Rates

The Affordable Care Act (ACA) was signed into law in 2010 and was gradually enacted over the next few years. One of the ACA’s many objectives was to reduce the cost of contraception and eliminate out-of-pocket costs for all pregnancy-capable individuals seeking birth control. While limited data has linked numerous benefits to this initiative, there is a lack of concrete data on the ACA’s effect on contraception, pregnancy, and abortion rates. The authors of this study explored this effect through the health care database of Kaiser Permanente, which serves more than four million patients. They evaluated contraception uptake and cost along with rates of pregnancy, birth, and abortion during the years before and after the ACA’s contraception cost reduction went into effect on January 1, 2013. In a sample size of more than 1.5 million reproductive-age females, they found that contraception uptake increased and pregnancy rates declined after the ACA was enacted. Abortion rates, which had already been declining prior to the ACA, continued to decline but at a slower rate, most likely due to fewer pregnancies and increased contraception use. This study highlights the importance of contraception access in allowing patients to achieve their desired pregnancy goals.

5. Abortion Surveillance - United States, 2022

The CDC has released its abortion surveillance data analysis from 2022. A total of 613,383 legal abortions were reported to the CDC during 2022 from 48 reporting areas (46 states, Washington DC, and New York City; California, Maryland, New Jersey, and New Hampshire were not included). Compared to previous numbers from these regions, the number of total abortions decreased by 2% since 2021, and the abortion rate (abortions per woman) and abortion ratio (abortions per live births) decreased by similar percentages. People in their 20s accounted for the majority of abortions, at 56%. Abortions were least common among individuals less than 15 years old or more than 40 years old (0.2% and 3.6%, respectively), though adolescent patients had the highest abortion ratios. In terms of gestational duration, 92.8% of abortions were performed at less than 13 weeks gestation. Among patients at less than 9 weeks gestational duration, 70% were medication abortions. This data can be used to guide policy making and public health interventions to ensure patients have access to the reproductive care necessary to achieve reproductive well-being.

6. ACOG Committee Statement No. 13: Self-Managed Abortion

Self-managed abortion (SMA) refers to actions people take to end a pregnancy outside the formal health care system. In this ACOG Committee Statement, the authors describe the reasons and methods patients might choose SMA, as well as appropriate care and support for these patients by providers who may interact with them. While SMA is necessarily difficult to study, many barriers may lead patients to choose SMA through different methods, including misoprostol with or without mifepristone, other drugs or herbs, or physical trauma. The authors encourage a policy of harm reduction for providers caring for patients who have chosen SMA and speak out against reporting mandates or prosecution of pregnant people that could lead to potential harm or negative consequences. The authors discuss that providers should be mindful in caring for and documenting when caring for patients who may have undergone SMA and remind them to be aware of the local and state level regulations that may affect their safety. Providers should be thoughtful about what information they truly need to collect to provide appropriate care without increasing the patient’s risk of criminalization, and any complications of SMA should be managed similar to spontaneous pregnancy losses.

7. Beliefs and behaviors regarding abortion counseling among U.S. clinicians caring for adolescents

Adolescents may encounter a diverse group of health care providers in early pregnancy, as they have typically do not have established gynecologic care. It is already well documented that adolescents experience significant barriers to abortion access, an issue that has only worsened since the Dobbs decision in June 2022. To understand the options counseling that clinicians provide to pregnant adolescents, the authors of this study performed a survey on providers who care for this patient population. The participants of the study included MDs, DOs, and advanced practice providers within the specialties of pediatrics, family medicine, and internal medicine distributed throughout the United States. Fifty-seven percent of providers reported routinely discussing abortion with patients, and 76% did not “routinely advise against termination”. Participants did acknowledge that personal beliefs and state laws influenced their counseling around pregnancy options for adolescents. These results highlight the presence of clinician bias in options counseling for this vulnerable patient population and suggest that there is an ongoing need for outreach and education for both adolescents and clinicians.

8. Test or no-test: Comparison of medication abortion outcomes and adverse events when forgoing ultrasound, laboratory testing, and physical examination

Medication abortion, the most common type of abortion worldwide, is extremely safe. Evidence supports its use even without ultrasound imaging to establish gestational duration, though some providers may not be comfortable with this approach. During the COVID 19 pandemic, many abortion providers altered their policies so that patients could access care remotely, either by eliminating requirements for specific tests or providing telehealth-based care. The Willow Reproductive Health Centre in Canada enacted a fully no-test medication abortion protocol during the pandemic, which provided researchers with an opportunity to compare these outcomes to those of patients who underwent sonographic and laboratory testing before their medication abortions. The test and no test groups each included more than 400 patients. The authors found that the overall success rate of medication abortion was 95.2% across both groups, and the rate of adverse events were low, with no difference between the test and no-test cohorts. Patients with significant risk factors for ectopic pregnancy or anemia were not eligible for the no-test protocol. These results add to the established safety of no-test abortion when provided to appropriately screened patients. This evidence, part of a growing body of research on this topic, can be used to increase abortion access throughout the United States and the world.

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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