Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

• Status: Terminated
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Treatments: Mifepristone; Misoprostol

Criteria

Inclusion Criteria:

• Ultrasound examination demonstrating:

1. Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR

2. Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart.

• If fetus exists, fetal size less than 12 weeks+6 days

• Closed cervical os

• Eligible to consent for research according to local regulations

Exclusion Criteria:

• Active bleeding at enrollment and/or history of bleeding within the prior week

• Allergies or other contraindications to the use of mifepristone or misoprostol

• Suspected ectopic pregnancy

• History of trophoblastic disease

• Coagulation disorder and/or currently taking anticoagulants

• Any serious medical condition