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

Gynuity Health Projects

Status: Completed

Conditions: Incomplete Abortion

Treatments: Drug: 600 mcg misoprostol; Procedure: Surgical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00674232

2.2.0

Details and patient eligibility

About

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.

Enrollment: 311 patients

Sex: Female

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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311 participants in 2 patient groups

Misoprostol

Experimental group

Description:

Group 1 randomized to take single dose of 600 mcg oral misoprostol

Treatment:

Drug: 600 mcg misoprostol

Surgical treatment

Other group

Description:

Group 2 randomized to receive standard surgical treatment as per local protocol (D\&C or MVA)

Treatment:

Procedure: Surgical treatment