A double-blind, randomised, controlled multicentre trial of misoprostol treatment prior to Vacuum Aspiration for termination of early pregnancy
Completed
- Conditions
- Termination of early pregnancy by vacuum aspirationPregnancy and ChildbirthTermination
- Registration Number
- ISRCTN98284169
- Lead Sponsor
- DP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 4984
Inclusion Criteria
1. Women requesting abortion and eligible for legal termination of normal single intrauterine pregnancy of less than 12 completed weeks (84 days) of gestation
2. Consent to participation
3. Able to understand information on the study
4. Agree to return for the scheduled follow-up visit
Exclusion Criteria
Women are not eligible if they have:
1. A medical condition or disease that requires special treatment, care of precautions in conjunction with vacuum aspiration
2. Allergy to misoprostol
3. Contraindications to misoprostol
4. Anaemia or any coagulation disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complication rates in misoprostol and placebo groups, measured during the procedure, in the immediate post-operative period, and up until the follow-up visit 7 to 14 days after the procedure
- Secondary Outcome Measures
Name Time Method 1. Ease of the procedure (dilation, duration of procedure, pain level), measured during the procedure<br>2. Side-effects, measured at any time after administration of misoprostol until the end of the study