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Early pregnancy loss medical management in clinical practice

This study aimed to review clinical practice outcomes of early pregnancy loss (EPL) medical management using mifepristone and misoprostol outside of a clinical trial setting. In this retrospective cohort study, we reviewed a deidentified database of patients who received mifepristone-misoprostol for...

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Published in:Contraception (Stoneham) 2023-10, Vol.126, p.110134-110134, Article 110134
Main Authors: Baker, Courtney C., Wu, Brenda T., Han, Gloria, Flynn, Anne N., Creinin, Mitchell D.
Format: Article
Language:English
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Summary:This study aimed to review clinical practice outcomes of early pregnancy loss (EPL) medical management using mifepristone and misoprostol outside of a clinical trial setting. In this retrospective cohort study, we reviewed a deidentified database of patients who received mifepristone-misoprostol for EPL from May 2018 to May 2021 at our academic center–based clinic, which was a study site for a multicenter mifepristone-misoprostol EPL trial completed in March 2018. All patients received mifepristone 200 mg orally and misoprostol 800 mcg vaginally or buccally, with clinic follow-up typically scheduled within 1 week. The primary outcome was successful medical management, defined as management without the need for aspiration, and the secondary outcomes included additional interventions and indications, follow-up ultrasonography findings, and adverse events requiring treatment. We treated 90 patients with a median ultrasound-measured gestational size of 49 (range 30–80) days and median time from mifepristone to misoprostol of 24 (range 8–66) hours. Follow-up was completed in clinic by 80 (88.9%), completed remotely by five (5.6%), and not completed by five (5.6%) patients. Overall, 76 (95% CI 82.9%–96.0%) of 85 patients (89.4%) with follow-up were successfully managed without uterine aspiration. Eighty patients had initial follow-up ultrasonography interpreted as gestational sac expulsion; seven (8.8%) of these ultimately underwent aspiration, including one patient who had a previously undiagnosed cesarean scar ectopic pregnancy. Two patients had significant safety outcomes: one pelvic infection and one blood transfusion during aspiration in the patient with a cesarean scar ectopic pregnancy. Outside of a clinical trial setting, medical management of EPL with mifepristone and misoprostol remains effective and safe. Medical management of EPL with mifepristone and misoprostol is effective and safe outside of a clinical trial setting. A standardized protocol based on the best available clinical trial evidence can be used in clinical practice for the medical management of EPL.
ISSN:0010-7824
1879-0518
DOI:10.1016/j.contraception.2023.110134