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

Gynuity Health Projects

Status and phase: Terminated; Phase 3

Conditions: Fetal Death

Treatments: Drug: Placebo; Drug: Misoprostol 200mcg; Drug: Mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT02633761

1019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

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

Treatment:

Drug: Mifepristone

Drug: Misoprostol 200mcg

Group 2

Placebo Comparator group

Description:

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

Treatment:

Drug: Misoprostol 200mcg

Drug: Placebo