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

Phase 3

Terminated

• Conditions: Fetal Death
• Interventions: Drug: Placebo; Drug: Mifepristone; Drug: Misoprostol 200mcg

• Registration Number: NCT02633761
• Lead Sponsor: Gynuity Health Projects

Brief 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.

Detailed Description

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. This will be a randomized controlled double-blinded trial of 150 women comparing misoprostol alone to mifepristone plus misoprostol for evacuation of the uterus after fetal demise in the second and third trimester. All women in the trial will undergo routine screening and pre-medical induction care per standard practice at the hospital.

All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens:

1. STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours;

2. STUDY GROUP TWO: placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.

Study Timeline

• Study Start: 2015-04-01
• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-14
• Study First Posted: 2015-12-17
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Misoprostol 200mcg	200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours
Group 2	Placebo	placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.
Group 2	Misoprostol 200mcg	placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.
Group 1	Mifepristone	200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours

Primary Outcome Measures

Name	Time	Method
Complete uterine evacuation of the fetus and placenta without surgical intervention	48 hours	Complete uterine evacuation of fetus and placenta using study drug alone without recourse to any additional surgical intervention

Trial Locations

Locations (3)

Hospital General "Enrique Cabrera"; 🇲🇽 Mexico City, Mexico

National Institute of Perinatology (INPer); 🇲🇽 Mexico City, Mexico

National Ob-Gyn Hospital; 🇻🇳 Hanoi, Vietnam