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Research roundup: 2023 highlights

Highlighting one notable research article from each Research Roundup in 2023.
By Robin Watkins, CNM, WHNP-BC | Dec 29, 2023
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Gabapentin as an adjunct for pain management during dilation and evacuation: a double-blind randomized controlled trial – (January)

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.

Mailing abortion pills does not delay care: a cohort study comparing mailed to in-person dispensing of abortion medications in the United States – (February)

No-test medication abortion, where patients are prescribed and mailed medication abortion via telehealth without in-person labs or ultrasound, is an important option for patients who are not interested in or unable to easily access in-person abortion care. However, there is some concern that the use of telehealth and mailing services may lead to delays, increased gestational age at the time of abortion, and accordingly decreased effectiveness of medication abortion when compared to in-person medication abortion visits. In this retrospective cohort study, the authors identified nearly 3,800 patients who had either in-person or no-test medication abortions. They determined that while there was an additional two to three days between dispensing medication abortion and taking mifepristone in the no-test group while medications moved through the mail, there was no significant difference in the time from first contact with a health care provider to dispensing medication abortion, or in the gestational age at the time of taking mifepristone between the two groups. The authors conclude that the mailing time for no-test medication abortions does not lead to clinically significant delays. Providers considering no-test medication abortion care models in their practices should counsel patients about the short delay associated with shipping medications while feeling confident that this practice does not affect efficacy overall.

Medication abortion with misoprostol-only: a sample protocol – (March)

Medication abortion is a safe and effective and is currently used by more than half of all patients seeking abortion in the US. The combination of mifepristone followed by misoprostol is FDA-approved for patients up to 70 days’ of gestation. However, as recent anti-choice lawsuits have the potential to significantly decrease access to mifepristone, this summary article describes protocol options and data supporting the use of misoprostol alone for effective and safe medication abortion. While the authors discuss that misoprostol-only regimens may be slightly less effective overall than regimens that also use mifepristone, success rates remain quite high, with successful abortion in 87-93% of patients in several large trials. Data also showed a low likelihood of ongoing pregnancy, at 3-6%, and <1% risk of bleeding requiring transfusion. Based on these findings, the authors provide a sample protocol for providing misoprostol-only medication abortion, including dosing and recommended follow-up. While ongoing political battles continue to unjustly threaten patients’ access to reproductive health care, providers can use this data to counsel patients, support their decision-making, and continue to offer high-quality alternatives in a changing political landscape.

Experiences of progestin-only pill users in the United States and attitudes toward over-the-counter access – (April)

Oral contraceptive pills are one of the most widely used forms of contraception in the United States, but for some individuals, obtaining access to a prescription can be prohibitive. An increasing body of evidence supports the provision of contraceptive pills without a prescription requirement, but less is known about patient perspectives on progestin-only pills, or POPs. While POPs are less frequently prescribed than combined oral contraceptives, they remain a feasible and safe option for numerous patients. The authors of this study led online focus group discussions for 36 POP users to better understand their perspectives regarding their chosen birth control method and the possibility of obtaining it over the counter (OTC). They found that the majority of POP users were happy with their method and found it easy to use, despite the need to take it at the same time every day. The vast majority of users expressed strong support for OTC access to POPs, particularly if pills were affordable and educational materials were available. The findings of this study indicate that POPs, if made available OTC, would be an acceptable and effective option for patients, adding to the existing literature on this topic. Learn more about the safety and efficacy of OTC pills and why we are ready for them now.

Vaginal swab vs urine for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis: a meta-Analysis – (May)

Chlamydia, gonorrhea, and trichomonas are some of the most common, and most commonly tested, sexually transmitted infections (STIs) worldwide. While the Centers for Disease Control and Prevention (CDC) recommends a vaginal swab, either provider- or patient-collected, for diagnosis, a large proportion of STI testing is performed through urine testing. Concerned that urine testing might miss an unacceptable proportion of STIs, the authors of this study performed a meta-analysis to evaluate the sensitivity of vaginal swabs compared to urine testing for commercially available assays for chlamydia, gonorrhea, and trichomonas. A total of 28 studies were evaluated. The authors found that sensitivity estimates for vaginal swabs compared to urine, respectively, were 94.1% and 86.9% for chlamydia, 96.5% and 90.7% for gonorrhea, and 98.0% and 95.1% for trichomonas. These comparisons demonstrate that there is a significant difference in sensitivity between these two test modalities, particularly for chlamydia and gonorrhea. Overall, the results of this study support existing CDC recommendations and suggest that vaginal swabs should be used preferentially when testing for these STIs.

Awareness of medication abortion among a nationally representative U.S. sample, 2021-2022 – (June)

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.

Effectiveness of self-managed medication abortion between 9 and 16 weeks of gestation – (July)

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.

Oral emergency contraception with levonorgestrel plus piroxicam: a randomised double-blind placebo-controlled trial – (August)

In the United States, the only over-the-counter (OTC) form of emergency contraception (EC) is a single 1.5mg dose of oral levonorgestrel (LNG) EC (Plan B and generics). LNG EC is a safe and effective option when used up to 72 hours after intercourse and while LNG EC can be taken up to 125 hours after intercourse, its effectiveness decreases over time and significantly after 72 hours. Additionally, LNG EC is not effective if taken after ovulation, and patients using LNG EC still have a 1-3% risk of pregnancy. Piroxicam, an oral COX-inhibitor, has the potential to further decrease the risk of pregnancy given its known effects on human ovulation. In this randomized placebo-controlled trial, researchers recruited 860 patients seeking LNG EC and randomized them to receive either LNG EC plus 40mg of piroxicam or LNG EC plus a placebo. In their analysis, the authors found that pregnancy rates were significantly lower in the intervention group, with pregnancy rates of 0.2% compared to 1.7% in the control group. No differences in adverse events were noted between the groups. While more research is needed, this study shows a potential opportunity to improve the efficacy of EC for patients who prefer an oral option.

“I feel like it gives me what I need to know”: a qualitative study on adolescent perceptions of two contraceptive decision aids – (September)

Sexually active adolescents are among the least likely to use highly effective contraceptive methods. Patient-centered contraceptive counseling, such as developmentally tailored decision aids, can be a useful tool in helping to improve patient understanding and confidence in their contraception choices. In this cross-sectional qualitative study, the authors recruited 20 adolescents aged 15-19 years to provide feedback for two contraception decision aids in adolescent clinical care, from the Reproductive Health Access Project (RHAP) and Bedsider.org. In semistructured interviews, the participants reported that both decisional aids were helpful, and appreciated the clear discussion of side effects and a full range of options. While participants differed in the amount of detailed information they preferred in a decisional aid, both aids increased adolescents’ self-reported knowledge. Decisional aids can provide a useful tool in guiding conversation and promoting patient-centered care in contraceptive visits with adolescents.

Induced abortion and the risk of Rh sensitization – (October)

Patients who have RhD-negative red blood cells may develop anti-D antibodies during pregnancy if they are exposed to sufficient RhD-positive fetal red blood cells, a process called alloimmunization. This may cause potential complications for the current and future pregnancies. To prevent alloimmunization, RhD-negative pregnant patients historically received Rh immunoglobulin, “Rhogam”, at any time in pregnancy where fetal blood exposure is possible, including after abortion. However, population-level data and increasing bench research suggest that alloimmunization is rare for patients undergoing abortion before 12 weeks’ gestation. In this multinational observational prospective study, the authors measured circulating levels of fetal red blood cells in maternal blood samples in more than 500 patients undergoing procedural or medication abortion before 12 weeks’ gestation. They determined that 99.8% of all patients did not exceed the fetal red blood cell threshold necessary for maternal alloimmunization after abortion; one patient was noted to have an elevated fetal red blood cell count before an abortion that remained elevated afterward. The authors conclude that this study adds to the growing literature demonstrating that induced first-trimester abortion is not a risk factor for Rh alloimmunization and that blood type testing and management with Rh immunoglobulin is unnecessary before 12 weeks gestation.

Helping patients choose between pain control options for outpatient procedural abortion at less than 12 weeks gestation – (November)

Determining the best pain management regimen for a given patient during procedural abortion can be a difficult process, given the complex physical and psychological aspects of experiencing pain. The majority of first-trimester procedural abortions in the US use either local anesthesia or local anesthesia with moderate IV sedation, but both patients and providers may struggle with choosing a regimen that will maximize their satisfaction with the experience. In this prospective control study, the authors developed an instrument to try to predict patient satisfaction with pain control regimens during procedural abortion through 12 weeks’ gestation among patients choosing either local anesthesia only or local anesthesia with IV moderate sedation. In analyzing data from 149 patients, the researchers determined that while reported patient satisfaction was overall higher in the moderate sedation group (91% vs 66% in the local anesthesia group), only self-reported fear of a minor medical procedure was significantly predictive of decreased satisfaction in the local anesthesia group. Other variables, such as age, gestational age, anticipated pain, self-reported pain tolerance or anxiety, or history of previous deliveries or abortions were not predictive of satisfaction levels. The authors conclude that definitive predictors of patient satisfaction with local anesthesia remain elusive, and that providers should strive to provide evidence-based care and center individual patients’ preferences regarding pain regimens.

Written by Robin Watkins, CNM, WHNP-BC

Robin Watkins is the Director of Clinical Affairs and Medical Education at the Society of Family Planning. Robin is a midwife and women’s health nurse practitioner focused on expanding provider capacity to offer just, equitable, resonant, and high-quality sexual and reproductive health care. Robin provides clinical care in the Washington, DC area. When she is not talking sex or placing IUDs, you can find her riding her bike on the streets of DC or eating ice cream for dinner.

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abortion procedureadolescentsCenter for Disease Control (CDC)chlaymdiaclinical guidelinesclinical studiesclinical trialscombined oral contraceptivesconscious sedationdilation & evacuation (D&E)gestational durationgonorrhealevonorgestrel-based EC (Plan B)local anesthesiamedication abortionMisoprostol-only regimenmoderate sedationno-test medication abortion protocolover-the-counter (OTC) birth controlpain managementPiroxicamprogestin-only pillsReproductive Health Access Project (RHAP)RH negative treatmentRH testingself-managed abortion (SMA)shared decision-making (SDM)STI screening, testing and treatmenttelehealth medication abortiontrichomonasultrasound
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