400mcg Sublingual Misoprostol as First Line Treatment

Not Applicable

Completed

• Conditions: Incomplete Abortion
• Interventions: Drug: Misoprostol

• Registration Number: NCT01939457
• Lead Sponsor: Gynuity Health Projects

Brief Summary

Women presenting with incomplete abortion and eligible for treatment with misoprostol were offered 400mcg sublingual misoprostol for treatment. Based on existing literature, the study hypothesises that women can successfully be treated with misoprostol alone as first line treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2013-08-07
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-06
• Last Update Submitted: 2013-09-06
• Study First Posted: 2013-09-11
• Last Update Posted: 2013-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 641

Inclusion Criteria

• uterine size less than 12 weeks lmp
• open cervical os
• current or past vaginal bleeding
• willing to provide contact information for follow-up
• over 18 or with guardian consent

Exclusion Criteria

• suspicion of ectopic pregnancy
• intrauterine device in place
• bad general health (infection, anemia, shoc)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
misoprostol	Misoprostol	400 mcg misoprostol sublingually

Primary Outcome Measures

Name	Time	Method
complete abortion	1 year	number of complete abortion with misoprostol treatment alone

Trial Locations

Locations (1)

Guediawaye Health Center; 🇸🇳 Guediawaye, Senegal