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Research roundup: July 2023 edition

Continued support for misoprostol-only regimens for medication abortion and self-managed abortion between nine and 16 weeks gestation, the use of home pregnancy tests for follow-up care after a telehealth medication abortion, where adolescents and young adults go online to get abortion information, and disparities in recommended retesting for women with trichomonas vaginalis infections.

by Colleen Denny, MD and Emma Gilmore, MD

published 07/31/23

1. Pregnancy with retained intrauterine device: national-level assessment of characteristics and outcomes

IUDs provide highly effective contraception, with failure rates of less than one percent per year. However, the rare pregnancies that begin with an IUD in place are known to be at higher risk of complications if the patient opts to continue the pregnancy. In this serial cross-sectional study, the authors analyzed data from the Healthcare Cost and Utilization Project’s Inpatient Sample to determine the type and frequency of pregnancy-related complications that occurred with patients with a retained IUD at the time of delivery. They found preterm premature rupture of membranes (PPROM) (9.2%), fetal malpresentation (10.9%), intrauterine fetal demise (2.6%), retained placenta (2.5%), placenta abruption (4.7%), and placenta accreta (0.7%) were all increased among patients with a retained IUD during pregnancy. Patients were also more likely to have a previable loss <22 weeks gestation (3.4%) or periviable delivery (3.1%). This data is useful in counseling the rare patients who become pregnant with an IUD in place as they consider their options.

2. Disparities in adherence to retesting guidelines in women with Trichomonas vaginalis infection

Trichomonas vaginalis is the most common nonviral STI in the United States, and numerous studies have shown higher prevalence rates among non-Hispanic Black women. While the CDC recommends that patients with known trichomonas infections have repeat testing 3to 12 weeks after treatment to assess for possible reinfection, there is less information about how providers adhere to these retesting recommendations. In this retrospective cohort study, the authors identified nearly 800 patients seeking care at an OB-GYN clinic, both pregnant and non-pregnant, with an initial positive test for trichomonas. They found that only 27% of all patients with trichomonas had retesting within the recommended time frame, with 44% of the pregnant patients undergoing retesting. Non-Hispanic Black women were less likely to undergo retesting than non-Hispanic White women. Persistent positive rates on retesting were high across all groups, at 24% of the group overall and 33% of the pregnant sub-group. These data indicate that trichomonas reinfection after initial diagnosis and treatment is high but suggest that clinicians and institutions must improve their adherence to retesting guidelines to improve early identification and treatment of this common STI.

3. Evaluation of a New Model for Human Chorionic Gonadotropin Rise in Pregnancies of Unknown Viability

Pregnancy of unknown location (PUL) is a commonly used term to indicate that early in pregnancy a patient has a positive serum hCG, but the location of the pregnancy, either intrauterine or extrauterine, cannot yet be determined. PULs are often at such an early stage that the viability of the pregnancy, even if it is growing in an intrauterine location, is also unclear. Traditionally, these PULs are carefully followed with serial hCG measurements and pelvic ultrasound until it is determined whether the pregnancy is a viable intrauterine pregnancy, an intrauterine early pregnancy loss, or an ectopic pregnancy. Protocols to make this definitive diagnosis must balance the risk of misdiagnosing a viable, desired intrauterine pregnancy with the risk of delaying diagnosis of an abnormal or ectopic pregnancy. In this retrospective cohort study, the authors identified nearly 700 patients who had been followed as PULs with serial lab draws and ultrasounds. They created a new model calculating additive percentage rise in sequential hCG draws on Day 1 (day of diagnosis), Day 4, and Day 6: if the total additive percent rise of hCG interval was 70% or greater at Day 4, the pregnancy was classified as potentially viable. Alternatively, if the initial rise was less than 70% but the rise at Day 6 was 200% or greater compared to the initial value on Day 1, this was also classified as potentially viable. In comparing this new model with traditional models for classifying hCG rise, the authors found that the new model optimized rates of correct classification for viable pregnancies, early pregnancy losses, and ectopic pregnancies without increasing unnecessary interventions or risks related to delayed/missed diagnosis. While the authors caution that further validation is needed with larger patient groups, this new model potentially represents an improved method for managing PULs and improving early pregnancy care.

4. Oral contraceptives containing drospirenone for premenstrual syndrome

Premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) are conditions in which premenstrual symptoms cause significant impairment or distress and have an estimated prevalence of 20-40% and 1-8% respectively. Combined oral contraceptive pills (COCs) containing drospirenone were approved by the FDA for the treatment of PMDD in 2006, but research has demonstrated a small but significant increase in venous thromboembolism risk for these pills compared to COCs containing levonorgestrel. In this Cochrane review, the authors examined five randomized controlled trials of 858 women total to determine how the use of COCs containing drospirenone impacted patients diagnosed with PMS or PMDD. They determined that the evidence was of very low to moderate quality, but that COCs containing ethinyl estradiol and drospirenone may improve PMS symptoms in patients with functional impairments due to PMDD in comparison to placebo. They were unable to conclude whether drospirenone helps patients with less severe symptoms, or whether COCs with drospirenone are superior to other formulations of COCs for PMS or PMDD. Providers seeing patients with significant PMS symptoms who desire medical management may consider a drospirenone-containing COC as an initial prescription.

5. Clinical outcomes of medication abortion using misoprostol-only: a retrospective chart review at an abortion provider organization in the United States

Medication abortion using a two-drug regimen of mifepristone and misoprostol provides a highly safe and effective method of ending a pregnancy. However, mifepristone may be unavailable or inaccessible in some regions, and misoprostol-only regimens for medication abortion can also be used as an acceptable alternative. These regimens are less commonly used in the US but may provide important alternatives if mifepristone access becomes restricted in the future. In this study, the authors analyzed outcomes among 911 patients who had a medication abortion using one of two misoprostol-only regimens during the COVID-19 pandemic. Among the 475 (52%) of patients for whom abortion outcomes were known, the authors determined that 82% of patients had a complete abortion and that 9% of patients had an ongoing pregnancy. Serious adverse events were reported for 0.3% of patients with known outcomes. The authors note that the 82% complete abortion rate is lower than other reported completion rates for misoprostol-only regimens, which typically range from high 80s to low 90s percentiles; they discuss this may be related to the low levels of follow up seen in this study, possibly due to more patients who recognize their own successful abortions not returning for care. Regardless, this study provides more evidence for the high levels of safety and efficacy of misoprostol-only medication abortion regimens.

6. Implications of using home urine pregnancy tests versus facility-based tests for assessment of outcome following medication abortion provided via telemedicine

There are numerous ways to confirm the successful completion of medication abortion (MAB), including ultrasound, serum pregnancy test via clinical blood draw, or urine pregnancy test, including home testing. While a home pregnancy test may be more convenient for patients, it is typically recommended around four weeks after their medication abortion, which may raise concerns about delays in follow-up or delayed recognition of failed or incomplete MAB. As telehealth MAB becomes more widely utilized, urine pregnancy tests are an increasingly fundamental component of follow-up care. In order to assess concerns about urine pregnancy tests as a follow-up option, the authors of this paper performed a secondary analysis of the TelAbortion Project, a large 5-year study of telehealth medication abortion. The authors reviewed data on more than one thousand participants who received follow-up via home pregnancy test and compared their outcomes to patients who had clinic follow-up. They found that there were no differences between groups in terms of completion of abortion or delay in detection of incomplete abortion. Patients using a home test did have a higher probability of an unplanned clinic visit but had fewer clinic visits overall. These results suggest that home urine pregnancy tests are safe and appropriate follow-up options for patients undergoing medication abortion.

7. Effectiveness of Self-Managed Medication Abortion Between 9 and 16 Weeks of Gestation

The effectiveness of self-managed medication abortion has been well-established in the early first trimester, but there is less data on this process at or beyond nine weeks gestational age. While the World Health Organization (WHO) endorses self-managed abortion up to 12 weeks gestational age, there is limited evidence to suggest that it is effective even into the second trimester. For this study, the authors conducted a prospective observational cohort study to examine outcomes for patients undergoing self-managed medication abortion between 9-16 weeks gestational age. Participants were recruited from Argentina, Nigeria, and Southeast Asia, and once approved for eligibility, were enrolled in the study. They underwent multiple follow-up calls to assess the completion of abortion, which was the primary outcome, along with their personal experience and whether they sought assistance from a health care provider. 89.4% of this cohort experienced a complete abortion without a procedure, and 23.5% sought a health care provider. Later gestational age was associated with the likelihood to seek assistance or information at a clinic. Overall the results of this study suggest that self-managed abortion could be safe and feasible beyond the second trimester, though further exploration is needed.

8. Confidentiality and Contraception: Protecting Adolescent Care in Response to One State's "Parents' Bill of Rights"

Confidentiality is a barrier to access for adolescents seeking reproductive health care services, as many states require varying amounts of disclosure to parents or guardians. Despite protections enacted by Title X funding that aim to provide confidential contraception services to adolescents, multiple states have created legislation that directly contradicts such protections. Oklahoma, for example, has created a “Parents’ Bill of Rights” which requires parental consent for any contraception provision to an adolescent patient. In an attempt to protect and support adolescent patients, the Adolescent Medicine clinic at the University of Oklahoma created a consent form requesting that parents waived their right to access confidential portions of the patient’s medical record, including waiving their right to consent for contraception on behalf of the adolescent. This study analyzed parents’ responses to this consent form. The vast majority of parents were willing to waive their rights to access their adolescent child’s health information, including 84% of parents allowing providers to prescribe contraception and 66% consenting for subdermal implant. Overall, these results suggest that parents are willing to allow adolescents to access confidential reproductive health care when they are presented with an explanatory document.

9. A Nationwide Sample of Adolescents and Young Adults Share Where They Would Go Online for Abortion Information After Dobbs v. Jackson

After Roe v Wade was overturned in June 2022, access to abortion has been decreasing around the United States. These changes are particularly acute for adolescents, who already face multiple barriers to abortion access due to laws around parental consent and confidentiality, along with later recognition of pregnancy and lack of access to funds for payment and travel. One additional barrier is the ability to obtain accurate and trustworthy information on abortion care. Prior research on adolescents and reproductive health care has demonstrated that this cohort usually turns to their cell phones or the internet for information. The authors of this study conducted a phone survey to better understand the resources that adolescent patients would use to find out information about abortion. Of their entire cohort of 638 adolescents, the majority could identify an online resource for abortion information, but many were unaware of further specifics or had concerns about the confidentiality of web searches. These results demonstrate that adolescent patients need additional education and training regarding safe ways to conduct online research and accurate resources on abortion and reproductive health care.

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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