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

Sponsor

Gynuity Health Projects (Other)

Overall Status

Terminated

CT.gov ID

NCT02633761

Collaborator

(none)

200

Enrollment

Locations

Arms

Actual Duration (Months)

66.7

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Death	Drug: Mifepristone Drug: Placebo Drug: Misoprostol 200mcg	Phase 3

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:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Dec 30, 2018

Actual Study Completion Date :

Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours	Drug: Mifepristone 200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours. Drug: Misoprostol 200mcg Buccal misoprostol 200mcg
Placebo Comparator: Group 2 placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.	Drug: Placebo placebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours. Drug: Misoprostol 200mcg Buccal misoprostol 200mcg

Arm

Intervention/Treatment

Active Comparator: Group 1

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

Drug: Mifepristone

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

Drug: Misoprostol 200mcg

Buccal misoprostol 200mcg

Placebo Comparator: Group 2

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

Drug: Placebo

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

Drug: Misoprostol 200mcg

Buccal misoprostol 200mcg

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.