Misoprostol for the Treatment of Incomplete Abortion - Tabular View

Tracking Information

First Received Date ^ICMJE

April 29, 2008

Last Updated Date

May 1, 2008

Start Date ^ICMJE

July 2004

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00670761 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Misoprostol for the Treatment of Incomplete Abortion

Official Title ^ICMJE

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

Brief Summary

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:

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

In Moldova and Madagascar:

600 mcg of oral misoprostol in one dose, or
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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Abortion, Incomplete

Intervention ^ICMJE

Drug: misoprostol
Procedure: MVA

Study Arms / Comparison Groups

Active Comparator: treatment with 600mcg oral misoprostol
Active Comparator: treatment with 400mcg sublingual misoprostol
Active Comparator: treatment with Manual Vacuum Aspiration (MVA)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

720

Completion Date

April 2007

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

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;

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Madagascar, Moldova, Republic of, Mozambique, Tanzania

Administrative Information

NCT ID ^ICMJE

NCT00670761

Responsible Party

Beverly Winikoff, MD, MPH, Gynuity Health Projects

Study ID Numbers ^ICMJE

2.2.1

Study Sponsor ^ICMJE

Gynuity Health Projects

Collaborators ^ICMJE

Befelatanana Maternity Centre Antananarivo, Madagascar
Municipal Clinical Hospital No. 1, Chisinau, Republic of Moldova
Kagera Regional Hospital, Bukoba, Tanzania
Jose Macamo Hospital, Maputo Mozambique

Investigators ^ICMJE

Principal Investigator:

Beverly Winikoff, MD, MPH

Gynuity Health Projects

Information Provided By

Gynuity Health Projects

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP