Late Breaking Original Research
Sunday, October 13, 2024
12:45 PM–02:15 PM
Abstract
Introduction: Mifepristone is approved for the termination of intrauterine pregnancy and has an off-label indication for early pregnancy loss. Its efficacy and safety in combination with misoprostol for the resolution of miscarriage and intrauterine fetal death has not been established.
Research Question or Hypothesis: Demonstrate the efficacy and safety of mifepristone and misoprostol together (intervention) compared to misoprostol alone (comparator) for the resolution of miscarriage and intrauterine fetal death.
Study Design: Systematic review and meta-analysis conducted through July 2024.
Methods: A systematic review and meta-analysis was conducted following the PRISMA methodology. It included randomized controlled trials (RCTs) that evaluated the efficacy and safety of mifepristone and misoprostol together compared to misoprostol alone for the resolution of miscarriage and intrauterine fetal death. Primary endpoints were overall delivery success, 24-hour delivery success, and incidence of safety outcomes. A p-value of <0.05 was considered statistically significant and heterogeneity was reported as the I2 value. Confidence intervals were reported to assess confidence.
Results: Twelve RCTs were included. Overall delivery success was higher in the intervention group (0.73 [CI 0.64–0.82], p<0.01). Twenty-four-hour delivery rate was higher (1.54 [CI 1.32–1.77], p=0.06) and a shorter time to delivery interval (9.22–18.78 vs 15.47–37.1 hours) was observed in the intervention group. Safety outcomes including blood transfusion (-0.01 [CI -0.10–0.09], p=0.88), infection (-0.02 [CI -0.11–0.07], p=0.90), postpartum hemorrhage (0.02 [CI -0.27–0.31], p=0.90), neurologic adverse effects (0.07 [CI -0.00–0.15], p<0.66), and fever (-0.00 [CI -0.15–0.14], p=0.82) did not show a statistically significant difference between groups. Gastrointestinal adverse effects were more frequent in the intervention group (0.04 [CI -0.03–0.12], p<0.01).
Conclusion: Mifepristone and misoprostol together demonstrated higher delivery success rates and comparable safety outcomes compared to misoprostol alone. The use of mifepristone and misoprostol together for the resolution of miscarriage and intrauterine fetal death is warranted over the use of misoprostol alone.
Presenting Author
Rachael Pirrami BSPSCleveland Clinic Health System
Authors
Justin Reinert Pharm.D., MBA, BCCCP
University of Toledo