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

Not Applicable

Completed

• Conditions: Incomplete Abortion
• Interventions: Procedure: surgery; Drug: misoprostol

• Registration Number: NCT00466999
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-04-25
• Study First Submitted QC: 2007-04-25
• Study First Posted: 2007-04-27
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
surgery	surgery	standard surgical treatment (either dilation and curettage or manual vacuum aspiration)
misoprostol	misoprostol	400 mcg misoprostol

Primary Outcome Measures

Name	Time	Method
Complete abortion without recourse to surgical intervention.	follow up visit 7 days after initial treatment

Trial Locations

Locations (6)

Maternite Issaka Gazobi; 🇳🇪 Niamey, Niger

Shatby Maternity Hospital/Alexandria University; 🇪🇬 Shatby, Alexandria, Egypt

Centre de Sante Le Roi Baudouin; 🇸🇳 Guediawaye, Senegal

Dandé District Hospital/Ziniaré District Hospital; 🇧🇫 Dande/Ziniare, Burkina Faso

El-Galaa Teaching Hospital; 🇪🇬 Cairo, Egypt

Cheikh Zayed Hospital; 🇲🇷 Nouakchott, Mauritania