drugset / Trial / NCT00592215

Second Trimester Labor Induction

NCT00592215

NaSingle-groupOpen-labelTreatment

Summary

A superior second trimester medical abortion regimen has not been identified. Studies suggest that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of adverse events. Narrowing the interval between the two medications without clinically reducing effectiveness may increase access and acceptability for patients and reduce costs. Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no studies on shorter intervals with same day administration between mifepristone and misoprostol in second trimester abortions. The primary objective is to assess the efficacy of the combined mifepristone/misoprostol regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8 hours between the two medications.

Timeline

Start
2008-03
Primary completion
2010-04
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Mifepristone Small molecule 200 mg
Subject Misoprostol Other / unclassified

Indications

No indication recorded.