drugset / Trial / NCT02957305

Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage

NCT02957305

Phase 4 Completed 211 enrolled Hospital de Clinicas de Porto Alegre
RandomizedParallel-groupTriple-blindTreatment

Summary

Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been recommended by some international guidelines . So far, there are no recent studies comparing cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg) for 6 hours. If cervical ripening is similar between these two regimens(i.e., 200µg regimen is not inferior to 400µg regimen), costs reductions and lower side effects may be issued without losing quality of cervix dilatation.

Timeline

Start
2016-12-21
Primary completion
2019-10-19
Completion
2020-06-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Misoprostol Other / unclassified 200 ug Other
Comparator Misoprostol Other / unclassified 400 ug Other

Indications

No indication recorded.