Incomplete Abortion Clinical Trial
Official title:
Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Verified date | February 2012 |
Source | Gynuity Health Projects |
Contact | n/a |
Is FDA regulated | No |
Health authority | Nigeria: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Nigeria | Adeoyo Maternity Hospital | Ibadan | |
Nigeria | University College Hospital, Ibadan | Ibadan |
Lead Sponsor | Collaborator |
---|---|
Gynuity Health Projects |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete abortion without recourse to surgical intervention | follow up visit 7 days after initial treatment | No |
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