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Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

Primary Purpose

Missed Abortion, Pregnancy

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Mifepristone
Misoprostol
Sponsored by
Gynuity Health Projects
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missed Abortion focused on measuring mifepristone, misoprostol, obstetrics, reproductive health, pregnancy, abortion, missed abortion

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Ultrasound examination demonstrating:

    1. Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR
    2. Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart.
  • If fetus exists, fetal size less than 12 weeks+6 days
  • Closed cervical os
  • Eligible to consent for research according to local regulations

Exclusion Criteria:

  • Active bleeding at enrollment and/or history of bleeding within the prior week
  • Allergies or other contraindications to the use of mifepristone or misoprostol
  • Suspected ectopic pregnancy
  • History of trophoblastic disease
  • Coagulation disorder and/or currently taking anticoagulants
  • Any serious medical condition

Sites / Locations

  • Hospital Nacional Profesor Alejandro Posadas
  • CHU Libreville
  • Hospital General Valle Ceylan
  • Agha Khan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mifepristone-misoprostol regimen

Misoprostol alone regimen

Arm Description

After a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.

After a woman is determined eligible and signs the informed consent document, she will receive a placebo (of same shape and size of mifepristone) and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.

Outcomes

Primary Outcome Measures

Rate of successful evacuation of the uterus
uterine evacuation without the need for uterine aspiration or other surgery

Secondary Outcome Measures

Rate of successful evacuation without any additional intervention
uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention
Excessive bleeding or a complication for which a woman received treatment
Induction expulsion interval after misoprostol administration
time interval between misoprostol administration and the expulsion
Acceptability of assigned method to women

Full Information

First Posted
January 9, 2015
Last Updated
January 11, 2019
Sponsor
Gynuity Health Projects
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1. Study Identification

Unique Protocol Identification Number
NCT02342002
Brief Title
Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
Official Title
Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
lack of funding
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 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 purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.
Detailed Description
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) 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 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missed Abortion, Pregnancy
Keywords
mifepristone, misoprostol, obstetrics, reproductive health, pregnancy, abortion, missed abortion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
416 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mifepristone-misoprostol regimen
Arm Type
Experimental
Arm Description
After a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.
Arm Title
Misoprostol alone regimen
Arm Type
Placebo Comparator
Arm Description
After a woman is determined eligible and signs the informed consent document, she will receive a placebo (of same shape and size of mifepristone) and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Intervention Description
Mifepristone for treatment of missed abortion
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
Misoprostol for treatment of missed abortion
Primary Outcome Measure Information:
Title
Rate of successful evacuation of the uterus
Description
uterine evacuation without the need for uterine aspiration or other surgery
Time Frame
1 week after treatment
Secondary Outcome Measure Information:
Title
Rate of successful evacuation without any additional intervention
Description
uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention
Time Frame
1 week after treatment
Title
Excessive bleeding or a complication for which a woman received treatment
Time Frame
30 days after treatment
Title
Induction expulsion interval after misoprostol administration
Description
time interval between misoprostol administration and the expulsion
Time Frame
one week follow-up
Title
Acceptability of assigned method to women
Time Frame
one week follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ultrasound examination demonstrating: Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart. If fetus exists, fetal size less than 12 weeks+6 days Closed cervical os Eligible to consent for research according to local regulations Exclusion Criteria: Active bleeding at enrollment and/or history of bleeding within the prior week Allergies or other contraindications to the use of mifepristone or misoprostol Suspected ectopic pregnancy History of trophoblastic disease Coagulation disorder and/or currently taking anticoagulants Any serious medical condition
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 Nacional Profesor Alejandro Posadas
City
Buenos Aires
Country
Argentina
Facility Name
CHU Libreville
City
Libreville
Country
Gabon
Facility Name
Hospital General Valle Ceylan
City
Tlalnepantla
Country
Mexico
Facility Name
Agha Khan University Hospital
City
Karachi
Country
Pakistan

12. IPD Sharing Statement

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Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

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