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Research roundup: January 2023 edition

A systemic review of “no-test” medication abortion, using an allis clamp during IUD placement, a trial of gabapentin for pain management during second-trimester abortions, and at-home urine pregnancy testing for follow-up of immediate management of an undesired pregnancy of unknown location.

by Colleen Denny, MD and Emma Gilmore, MD

published 01/31/23

1. No-Test Medication Abortion: A Systematic Review

While medication abortion has traditionally been offered to patients after an in-clinic assessment and verification of gestational age, “no-test” medication abortion has become a more common alternative for abortion care for patients who are not physically seen in a clinical setting. In this “no-test” model, patients are screened to determine whether they are safe and appropriate candidates for medication abortion without the use of a pelvic exam or ultrasound. While this care model reduces many of the barriers inherent in requiring an in-person assessment prior to an abortion, questions remain about its safety and efficacy. In this systematic review, the authors analyzed 21 studies involving more than 10,000 patients undergoing no-test medication abortion. They determined that the efficacy rate was 95.2% for patients undergoing medication abortion through 70 days gestation (the current FDA approval limit) and decreased to 83.8% efficacy past 84 days gestation. Follow-up procedure was uncommon for patients less than 70 days gestation, at 3.8%, and ectopic pregnancies were identified in only 0.02% of pregnancies through 70 days gestation and 0.06% overall. The authors conclude that this large data set shows that no-test medication abortion, similar to in-person medication abortion, is highly safe and effective for appropriate candidates and can serve as an important option for patients for whom in-person assessment represents a significant barrier to abortion access.

2. Acute complications with same-day versus overnight cervical preparation before dilation and evacuation at 14 to 16 weeks

Modern techniques for surgical abortion in the early second trimester generally involve cervical preparation using pharmaceutical and/or mechanical methods, but the safest and most effective timing of this preparation has not been determined. This question becomes particularly important for reducing barriers to abortion care, as two-day cervical preparation may significantly burden patients seeking care. In this retrospective cohort study, the authors identified more than 1,300 patients seeking abortion procedures between 14 and 16 weeks' gestation and received either same-day or overnight cervical preparation with misoprostol and/or osmotic dilators before their procedures. In analyzing acute complication rates, the authors found that same-day preparation was non-inferior to overnight preparation, with rates of 0.93% versus 1.98% in the respective groups. While the groups were not randomized, and the authors noted that patients in the same-day group were more likely to have had a history of vaginal delivery, they discuss that same-day cervical preparation should be considered for patients seeking abortion procedures early in the second trimester.

3. Gabapentin as an adjunct for pain management during dilation and evacuation: A double-blind randomized controlled trial

Appropriate pain control during abortion procedures is an important aspect of safe and patient-centered abortion care. While providers may use a combination of different local and intravenous anesthesia to manage pain during abortion procedures, less research has investigated the use of preoperative gabapentin, a GABA analog that has been shown to be effective for pain management for other procedures. In this randomized controlled trial of 126 participants seeking an abortion procedure between 14 and 19 weeks' gestation under moderate sedation, the researchers compared 600mg of preoperative gabapentin versus placebo and analyzed its effect on patient pain scores. While they found that recalled maximum pain scores did not significantly differ between the groups, pain scores were significantly lower in the gabapentin group specifically during the uterine aspiration portion of the case and overall fentanyl use was lower in this group. There was no difference in complication rates or side effects between the two groups. While the authors call for more research, they suggest that this data may show a potential role for gabapentin in abortion care.

4. At-home urine pregnancy test assessment after mifepristone and misoprostol for undesired pregnancy of unknown location

Patients with undesired pregnancies are recognizing their pregnancies and presenting for abortion care earlier than ever before; in 2019, nearly 43% of all abortions occurred at or before 6 weeks gestation. However, confirming an intrauterine pregnancy at this very early gestational age may be challenging, and such patients have historically been followed as pregnancies of unknown location (PULs) with serial lab draws and/or sonograms until a definitive intrauterine pregnancy is diagnosed. This type of serial follow-up for undesired PULs is burdensome for patients, and more recent research has begun to investigate alternative models of management, including immediate management with misoprostol and mifepristone and subsequent at-home urine pregnancy test (UPT). In this small prospective study following 13 patients with undesired PULs, researchers provided misoprostol and mifepristone to patients per standard medication abortion protocols and followed up their subsequent home UPTs and overall clinical outcome. Of the nine patients who had successful medication abortions and completed home UPTs, all were negative by 14 days after taking the mifepristone. While this study’s application is limited by its small sample size, it adds to a growing body of research that suggests that certain undesired PULs may be successfully managed with same-day medication abortion and home testing for follow-up alongside careful return precautions.

5. Association Between State-Level Access to Reproductive Care and Suicide Rates Among Women of Reproductive Age in the United States

Suicide is a major cause of death for young people who identify as women, and suicide rates may be affected by external factors such as environmental and interpersonal stressors. Prior studies have explored the ways that abortion restrictions can lead to stress and anxiety for pregnancy-capable people. However, little is known about the effect that restrictions on reproductive freedom have on suicide rates for reproductive-aged women. The authors of this study examined suicide rates in this population between the years 1974 and 2017, considering TRAP (Targeted Regulation of Abortion Providers) Laws to be the exposure of interest. They compared death rates due to suicide to death rates due to motor vehicle accidents in the same age groups, as this was a quantity that they did not expect to be affected by TRAP Laws. The authors found that enforcement of a TRAP law was associated with a 5.81% higher rate of suicide when compared to a pre-enforcement time period. These findings add to the growing body of evidence that abortion restrictions have a severe and irreversible effect on health outcomes for reproductive-aged women.

6. Does Ultrasound Guidance Provide Pain Relief during Intrauterine Contraceptive Device Insertion? A Systematic Review and Meta-Analysis of Randomized Controlled Trials

IUDs provide highly effective reversible contraception and are safe and effective for the majority of patients. Pain during the initial placement of the IUD, however, may be poorly controlled for some, and fear of pain during placement may even deter people who would otherwise be interested in using an IUD. In this systematic review and meta-analysis, the authors identified seven RCTs involving more than 1,200 patients to determine whether transabdominal ultrasound guidance affected the patients’ experience during IUD placement. In their analysis, they found a significant reduction in patients’ reported pain scores with the use of ultrasound guidance, as well as decreased procedure time and improved overall patient satisfaction. While the authors acknowledge that ultrasound guidance may not be feasible in all clinical scenarios, this data suggests that providers with access to ultrasound may be able to improve pain and satisfaction for patients undergoing in-office IUD insertions.

7. Cervical bleeding with cervical stabilization during IUD placement: allis clamp versus single-tooth tenaculum, a randomized control trial

Cervical stabilization, in which a provider grasps the cervix to provide traction and reduce flexion of the uterus, is an important part of safe gynecologic procedures. Stabilization is often performed with a single-tooth tenaculum, which can be traumatic to the cervix due to puncture injury. The tenaculum is traditionally used during intrauterine device (IUD) placement and may lengthen procedure time if it causes additional bleeding. To explore less traumatic options for cervical stabilization, the authors of this study compared the atraumatic Allis clamp with the single-tooth tenaculum for IUD placement. They found that the Allis clamp significantly reduced bleeding during the procedure, without negatively impacting the success of IUD placement. Interestingly, patients’ pain scores did not differ by clamp but did correlate with parity and type of IUD. Overall, these results suggest that providers can use an atraumatic clamp, such as an Allis, for cervical stabilization during IUD placement, without diminishing the success of the procedure.

8. Contraceptive Implant-Associated Bleeding in Adolescent/Young Adult Clinical Practice: Associated Factors, Management, and Rates of Discontinuation

The etonogestrel implant (Nexplanon), is a highly effective form of contraception, but it can have a bothersome bleeding profile. While unscheduled bleeding is a well-known side effect of the implant, less is known about how this is perceived by adolescent patients and its effect on implant discontinuation in this population. The authors of this study used a quality improvement database to analyze implants placed between 2014 and 2019, reviewing data on 825 adolescent Nexplanon users. Irregular bleeding was reported by 27% of implant users, and these patients were more likely to have multiple follow-up visits. However, more than 50% of this subgroup continued using the implant for three years, suggesting that unscheduled bleeding is not an insurmountable obstacle for many patients. These findings can be used for patient counseling and may be helpful for providers who care for an adolescent population.

9. Risk of thromboembolism in patients with COVID-19 who are using hormonal contraception

The use of combined hormonal contraception (CHC) methods, the pill, patch, and ring, increase an individual’s baseline risk of venous thromboembolism (VTE). COVID-19 also increases thrombotic risk, although the precise mechanism of this effect is still poorly understood. Based on these known risks, the authors of this Cochrane Review hypothesized that users of CHCs may have an increased risk of thrombosis or other complications if they become infected with COVID-19. They performed an extensive literature review, and ultimately found very few studies that addressed their questions. Overall, there is very limited, uncertain data suggesting that CHCs do not have a meaningful effect on COVID-19 outcomes, and no major conclusions can be made from these findings. The authors identified a need for further study on COVID-19 outcomes related to CHC use, as this information will continue to be relevant for reproductive-aged individuals who may become infected. This review contains useful information on the available data for CHC use and COVID-19-related thrombosis and severity.

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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