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

NCT02633761 | Terminated Phase 3 DMC

• 1 other identifier: 1019
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 3

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.

Conditions

Fetal Death

Keywords

Fetal death; mifepristone; misoprostol

Outcome Measures

Primary Outcomes (1)

• Complete uterine evacuation of the fetus and placenta without surgical intervention

  Complete uterine evacuation of fetus and placenta using study drug alone without recourse to any additional surgical intervention

  48 hours

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Drug: Mifepristone; Drug: Misoprostol 200mcg

Group 2

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Misoprostol 200mcg

Interventions

Mifepristone DRUG

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

Group 1

Placebo DRUG

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

Group 2

Misoprostol 200mcg DRUG

Buccal misoprostol 200mcg

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (3)

Hospital General "Enrique Cabrera"

Mexico City, Mexico

Location

National Institute of Perinatology (INPer)

Mexico City, Mexico

Location

National Ob-Gyn Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Fetal Death

Interventions

Mifepristone; Misoprostol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Hillary Bracken, PhD

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 17, 2015
• Study Start: April 1, 2015
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: February 11, 2019

Record last verified: 2019-01

Locations

ME (2); VN (1)