Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion in Nigeria

February 21, 2012 updated by: Gynuity Health Projects

Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 1

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

  • Nigeria
      • Ibadan, Nigeria
        • Adeoyo Maternity Hospital
      • Ibadan, Nigeria
        • University College Hospital, Ibadan

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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • no contraindications to misoprostol
  • uterine size was not larger than 12 weeks
  • there were no signs of severe infection
  • haemodynamically stable
  • in general good health
  • willing to provide contact information

Exclusion Criteria:

  • an IUD in place
  • ectopic pregnancy
  • aged below 18 years and had no accompanying adult to provide informed consent

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: Misoprostol
400 mcg of sublingual misoprostol in one dose
Drug: Misoprostol
single dose of 400 mcg misoprostol administered sublingually
Active Comparator: Manual vacuum aspiration (MVA)
Standard surgical treatment (MVA)
Procedure: surgery Manual vacuum aspiration (MVA)
standard surgical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete abortion without recourse to surgical intervention
Time Frame: follow up visit 7 days after initial treatment
follow up visit 7 days after initial treatment

Collaborators and Investigators

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

Sponsor

Gynuity Health Projects

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

August 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (Estimate)

February 27, 2012

Study Record Updates

Last Update Posted (Estimate)

February 27, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.2.3

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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