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

Not Applicable

Completed

• Conditions: Incomplete Abortion
• Interventions: Drug: 600 mcg misoprostol; Procedure: Surgical treatment

• Registration Number: NCT00674232
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study Completion: 2007-10
• Study First Submitted: 2008-04-28
• Status Verified: 2008-05
• Study First Submitted QC: 2008-05-05
• Last Update Submitted: 2008-05-05
• Study First Posted: 2008-05-07
• Last Update Posted: 2008-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 311

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol	600 mcg misoprostol	Group 1 randomized to take single dose of 600 mcg oral misoprostol
Surgical treatment	Surgical treatment	Group 2 randomized to receive standard surgical treatment as per local protocol (D\&C or MVA)

Primary Outcome Measures

Name	Time	Method
complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason	one week after initial treatment

Secondary Outcome Measures

Name	Time	Method
side effects	measured at follow up visit one week after initial treatment
acceptability	measured at follow up visit one week after initial treatment

Trial Locations

Locations (3)

Hospital Gineco-obstetrico Isidro Ayora; 🇪🇨 Quito, Ecuador

Hospital del Dia, CEMOPLAF; 🇪🇨 Quito, Ecuador

Hospital Maternidad Concepcion Palacios; 🇻🇪 Caracas, Venezuela