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

Fetal Death Clinical Trial

Official title:

Mifepristone and Misoprostol Versus Misoprostol Alone for Treatment of Fetal Death at 14-28 Weeks of Pregnancy: A Randomized, Placebo-controlled Double-blinded Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02633761
• Other study ID #: 1019
• Status: Terminated
• Phase: Phase 3
• Start date: April 1, 2015
• Est. completion date: December 30, 2018

Study information

• Verified date: January 2019
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Fetal Death

Intervention

Drug:
• Mifepristone
200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours.
• Placebo
placebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours.
• Misoprostol 200mcg
Buccal misoprostol 200mcg

Locations

Country	Name	City	State
Mexico	Hospital General "Enrique Cabrera"	Mexico City
Mexico	National Institute of Perinatology (INPer)	Mexico City
Vietnam	National Ob-Gyn Hospital	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Mexico,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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