drugset / Trial / NCT01033903

Optimal Treatment of Miscarriage

NCT01033903 ↗

Completed 190 enrolled Region Skane
RandomizedParallel-groupOpen-labelTreatment

Summary

The main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.

Timeline

Start
2008-10-01
Primary completion
2015-12
Completion
2018-03-01

Outcome

Met primary endpoint

paper In women with early non-viable pregnancy and vaginal bleeding, misoprostol treatment is more effective than is expectant management for complete evacuation of the uterus. PMID 29072372 ↗

paper Miscarriage was complete ≤ 10 days in 62/94 (66%) of the patients in the misoprostol group and in 39/90 (43%) PMID 29072372 ↗

paper risk difference (RD) = 23%; 95% CI, 8-37% PMID 29072372 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Misoprostol Other / unclassified 800 ug Other