Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death

• Status: Terminated
• Trial end date: 2018-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• Demised fetus of between 14 to 28 weeks duration confirmed by ultrasound

• Have no contraindications to study procedure, according to provider

• Be able to consent to procedure, either by reading consent document or by having consent document read to her

• Be willing to follow study procedures.

Exclusion Criteria:

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

• Placental abruption with active hemorrhage,

• Complete placenta previa, extreme uterine structural anomalies, or other contradictions to vaginal delivery of the fetus;

• Presentation in active labor (moderate to severe contractions every 10 minutes or less);

• Transmural uterine scars;

• Four or more previous deliveries.