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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fetal Death

Intervention / Treatment
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* Drug: Mifepristone
* Drug: Placebo
* Drug: Misoprostol 200mcg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal death, mifepristone, misoprostol