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

Primary Purpose

Fetal Death

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mifepristone
Placebo
Misoprostol 200mcg
Sponsored by
Gynuity Health Projects
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Death focused on measuring Fetal death, mifepristone, misoprostol

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Hospital General "Enrique Cabrera"
  • National Institute of Perinatology (INPer)
  • National Ob-Gyn Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 8, 2015
Last Updated
February 7, 2019
Sponsor
Gynuity Health Projects
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1. Study Identification

Unique Protocol Identification Number
NCT02633761
Brief Title
Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynuity Health Projects

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Death
Keywords
Fetal death, mifepristone, misoprostol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Intervention Description
200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours.
Intervention Type
Drug
Intervention Name(s)
Misoprostol 200mcg
Intervention Description
Buccal misoprostol 200mcg
Primary Outcome Measure Information:
Title
Complete uterine evacuation of the fetus and placenta without surgical intervention
Description
Complete uterine evacuation of fetus and placenta using study drug alone without recourse to any additional surgical intervention
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Bracken, PhD
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General "Enrique Cabrera"
City
Mexico City
Country
Mexico
Facility Name
National Institute of Perinatology (INPer)
City
Mexico City
Country
Mexico
Facility Name
National Ob-Gyn Hospital
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Learn more about this trial

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

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