drugset / Trial / NCT00383032

Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction

NCT00383032 ↗

Completed 72 enrolled Dartmouth-Hitchcock Medical Center
RandomizedSingle-groupOpen-labelTreatment

Summary

Data from other countries have suggested that oral mifepristone used as a cervical ripening agent may decrease induction to delivery time in midtrimester inductions. To our knowledge, there are no trials comparing mifepristone to laminaria in a standard clinical setting with standardized misoprostol induction protocol to examine the issue of induction to delivery time. We hypothesize that mifepristone will work at least as well as laminaria for midtrimester cervical ripening prior to induction of labor with misoprostol.

Timeline

Start
2004-01
Primary completion
—
Completion
2006-06

Outcome

Met primary endpoint

paper Induction-to-delivery time was significantly shorter in the mifepristone arm (mean=10 h vs. 16 h, p=.01; median=7.5 h vs. 13.4 h, p=.01). PMID 17963864 ↗

paper Pain with cervical ripening was also significantly less in the mifepristone group than in the laminaria group (median=1 vs. 6 on an 11-point visual analogue scale, p<.001). PMID 17963864 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Mifepristone Small molecule — Oral

Indications

No indication recorded.