Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion in Nigeria
Phase 1
Completed
- Conditions
- Incomplete Abortion
- Interventions
- Procedure: surgery Manual vacuum aspiration (MVA)
- Registration Number
- NCT01539408
- Lead Sponsor
- Gynuity Health Projects
- Brief Summary
Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
Inclusion Criteria
- no contraindications to misoprostol
- uterine size was not larger than 12 weeks
- there were no signs of severe infection
- haemodynamically stable
- in general good health
- willing to provide contact information
Exclusion Criteria
- an IUD in place
- ectopic pregnancy
- aged below 18 years and had no accompanying adult to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Misoprostol Misoprostol 400 mcg of sublingual misoprostol in one dose Manual vacuum aspiration (MVA) surgery Manual vacuum aspiration (MVA) Standard surgical treatment (MVA)
- Primary Outcome Measures
Name Time Method Complete abortion without recourse to surgical intervention follow up visit 7 days after initial treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Adeoyo Maternity Hospital
🇳🇬Ibadan, Nigeria
University College Hospital, Ibadan
🇳🇬Ibadan, Nigeria