CLINICAL ORAL ABSTRACTS: Safety and efficacy of no-test medication abortion: A retrospective multi-site study

Abstract

<h3>Introduction</h3> The COVID-19 pandemic brought new attention to medication abortion because it does not require direct physical contact between patient and clinical staff. No-test approaches for medication abortion preserve the usual standard of care, except that they replace the in-person ultrasound or physical exam before the abortion with other evidence-based methods to assess the patient's duration of pregnancy and screen for ectopic pregnancy. Early in the pandemic, a no-test sample protocol was published to offer guidance for clinical practice. However, little has been published on the safety and efficacy outcomes of no-test approaches. <h3>Method</h3> Through webinars and personal contacts, we invited US-based clinics that had adopted the no-test medication abortion protocol to join the study. A no-test medication abortion was defined as not having a preabortion ultrasound or physical exam. Participating clinics abstracted data from medical records of all patients who received a no-test medication abortion and entered them into a REDCap database. We conducted descriptive analyses of the clinic protocols and the patient sample. We also developed a multilevel, multivariable model that accounted for clustering at the clinic-level to estimate the adjusted odds of medication abortion failure and adverse events. <h3>Results</h3> We included 11 clinics, 4 of which contributed some data from the TelAbortion Study. Clinics shared data on 791 patients served from Jan. 1 to Dec. 31, 2020. Among all patients, 58.1% received mifepristone in person and 41.9% received it by mail. At mifepristone provision, patients' pregnancy durations ranged from 27 to 74 days; 36.4% were <=42 days, 45.3% were 43 to 56 days, 16.4% were 57 to 70 days, and 1.9% were >71 days. We received at least some follow-up data for 626 patients (79.1%) and excluded 14 patients who did not take mifepristone. Of the remaining 612 patients, 5 (0.8%) experienced serious adverse events defined as hospital admission, abdominal surgery and blood transfusion. One patient had a confirmed ectopic pregnancy and was admitted to a hospital for salpingectomy 9 days after provision of mifepristone (included as a serious adverse event). Abortion outcome data were available for 394 patients (64.4%). Overall, 94.7% (95% CI: 92.0% to 96.7%) of patients had a complete abortion with <1600 mcg of misoprostol, without an aspiration, procedure, or more mifepristone and misoprostol. 2 patients had suspected or confirmed ongoing pregnancies. Outcomes were similar for those who received medications in-person and those who received them by mail. <h3>Conclusions</h3> No-test medication abortion with either in-person pick up or mailing of medications is effective and safe, with outcomes similar to rates found in the published literature. Moreover, omitting tests reduce COVID-19 risk and conform with FDA REMS requirements when combined with in-person pick up. Follow up rates (64.4%) with the NTMA approach were similar to other medication abortion protocols. Combining no-test medication abortion protocols with mailing of medications to patients would support public health efforts for those who want to avoid a clinic visit.