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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-11-30

Brief Summary

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In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.

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Detailed Description

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Conditions

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Incomplete Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgery

standard surgical treatment (either dilation and curettage or manual vacuum aspiration)

Group Type ACTIVE_COMPARATOR

surgery

Intervention Type PROCEDURE

standard surgical treatment (dilation and curettage or manual vacuum aspiration)

misoprostol

400 mcg misoprostol

Group Type ACTIVE_COMPARATOR

misoprostol

Intervention Type DRUG

single dose of 400 mcg misoprostol administered sublingually

Interventions

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misoprostol

single dose of 400 mcg misoprostol administered sublingually

Intervention Type DRUG

surgery

standard surgical treatment (dilation and curettage or manual vacuum aspiration)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Uterine size no larger than 12 weeks LMP at time of presentation for care.
* Past or present history of vaginal bleeding during pregnancy.
* Open cervical os.
* If ultrasound used 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.
* General good health.
* Willing to provide contact information for purposes of follow-up.
* Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger, Mauritania and Senegal).

Exclusion Criteria

* Contraindications to study drug
* Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever \> 38 degrees C , 3) uterine tenderness
* Hemodynamic disturbances (pulse \>110/min and systolic bp \<100)
* Have an IUD in place; (the IUD may be removed making the woman eligible)
* Suspected ectopic pregnancy

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes