Misoprostol for the Treatment of Incomplete Abortion

July 26, 2016 updated by: Gynuity Health Projects

Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options

This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion.

Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens:

In Tanzania and Mozambique:

  1. 600 mcg of oral misoprostol in one dose, or
  2. Standard surgical treatment (MVA)

In Moldova and Madagascar:

  1. 600 mcg of oral misoprostol in one dose, or
  2. 400 mcg of sublingual misoprostol in one dose.

In Burkina Faso and Vietnam:

1. 400 mcg of sublingual misoprostol in one dose.

We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Bobo Dioulasso, Burkina Faso
        • Hôpital de District Sanitaire Dandé
      • Ouagadougou, Burkina Faso
        • Hôpital de District Sanitaire de Ziniaré
  • Madagascar
      • Antananarivo, Madagascar
        • Befelatanana Maternity Centre
  • Moldova, Republic of
      • Chishinau, Moldova, Republic of
        • Municipal Clinical Hospital
  • Mozambique
      • Maputo, Mozambique
        • Jose Macamo Hospital
  • Tanzania
      • Bukoba, Tanzania
        • Kagera Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • If no ultrasound used:

    1. Past or present history of vaginal bleeding during pregnancy; and
    2. Open cervical os.

  • If ultrasound used:

    1. Past or present history of vaginal bleeding during pregnancy; and
    2. Evidence of incomplete abortion with substantial debris in the uterus.

All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.

  • Willing to provide contact information for purposes of follow-up.

    • In Tanzania: 18 years of age or over or parental permission
    • In Mozambique: 21 years of age or over or parental permission
    • In Moldova: 18 years of age or over
    • In Madagascar: 18 years of age or parental permission
    • In Vietnam: reproductive age

Exclusion Criteria:

  • Contraindications to the study drug;
  • Uterine size larger than 12 weeks L.M.P. at time of presentation for care.

  • Signs of severe infection, defined as at least one of the following of:

    1. foul smelling discharge,
    2. fever > 39 degrees C ,
    3. pulse >110/min;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
treatment with 600mcg oral misoprostol
Drug: misoprostol
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
Other Names:
  • Cytotec
Active Comparator: 2
treatment with 400mcg sublingual misoprostol
Drug: misoprostol
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
Other Names:
  • Cytotec
Active Comparator: 3
treatment with Manual Vacuum Aspiration (MVA)
Procedure: MVA
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason
Time Frame: one week after initial treatment with the option of an additional week
one week after initial treatment with the option of an additional week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Collaborators

Befelatanana Maternity Centre
Municipal Clinical Hospital No. 1
Kagera Regional Hospital
Jose Macamo Hospital
Tudu hospital
National OBGYN hospital
Cuchi General District hospital
Hôpital de District Sanitaire Dandé
Hôpital de District Sanitaire de Ziniaré

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 29, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (Estimate)

May 2, 2008

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.2.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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