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

NCT ID: NCT02633761

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2018-12-30

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.

Conditions

Fetal Death

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours

Group Type: ACTIVE_COMPARATOR

Mifepristone

Intervention Type: DRUG

200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours.

Misoprostol 200mcg

Intervention Type: DRUG

Buccal misoprostol 200mcg

Group 2

placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours.

Misoprostol 200mcg

Intervention Type: DRUG

Buccal misoprostol 200mcg

Interventions

Mifepristone

200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours.

Intervention Type: DRUG

Placebo

placebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours.

Intervention Type: DRUG

Misoprostol 200mcg

Buccal misoprostol 200mcg

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gynuity Health Projects

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hillary Bracken, PhD

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

Hospital General "Enrique Cabrera"

Mexico City, , Mexico

National Institute of Perinatology (INPer)

Mexico City, , Mexico

National Ob-Gyn Hospital

Hanoi, , Vietnam

Countries

Mexico; Vietnam

Other Identifiers

1019

Identifier Type: -

Identifier Source: org_study_id