Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment

May 5, 2008 updated by: Gynuity Health Projects

Misoprostol for Treatment of Incomplete Abortion

This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

311

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

  • Ecuador
      • Quito, Ecuador
        • Hospital Gineco-Obstétrico Isidro Ayora
      • Quito, Ecuador
        • Hospital del Dia, CEMOPLAF
  • Venezuela
      • Caracas, Venezuela
        • Hospital Maternidad Concepcion Palacios

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

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • past or present history of vaginal bleeding during pregnancy
  • open cervical os
  • evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound)
  • surgical evacuation of the uterus would be advised as course of action if misoprostol was not available
  • generally in good health
  • woman lives or works within one hour of study site
  • woman willing to provide contact information for follow up purposes
  • informed consent given

Exclusion Criteria:

  • contraindications to study drug
  • uterine size larger than 12 weeks LMP
  • signs of severe infection

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Misoprostol
Group 1 randomized to take single dose of 600 mcg oral misoprostol
Drug: 600 mcg misoprostol
single dose of misoprostol taken orally
Other Names:
  • Cytotec
OTHER: Surgical treatment
Group 2 randomized to receive standard surgical treatment as per local protocol (D&C or MVA)
Procedure: Surgical treatment
Either dilation and curettage or manual vacuum aspiration, as per local protocol
Other Names:
  • D&C, 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
one week after initial treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
side effects
Time Frame: measured at follow up visit one week after initial treatment
measured at follow up visit one week after initial treatment
acceptability
Time Frame: measured at follow up visit one week after initial treatment
measured at follow up visit one week 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

Helpful Links

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

May 1, 2006

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

April 28, 2008

First Submitted That Met QC Criteria

May 5, 2008

First Posted (ESTIMATE)

May 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2008

Last Update Submitted That Met QC Criteria

May 5, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.2.0

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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