Comparison of two routes and two intervals of administration of misoprostol for the termination of early pregnancy: a randomised multicentre trial
Completed
- Conditions
- Induced abortionPregnancy and ChildbirthAbortion
- Registration Number
- ISRCTN10531821
- 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
- 2100
Inclusion Criteria
1. Healthy women, eligible for and requesting medical abortion
2. Agrees to surgical termination should method fail
Exclusion Criteria
1. Any indication of serious past or present illness
2. Allergic to misoprostol or with a strong allergic tendency in general
3. Heavy smokers (greater than 20 cigarettes a day)
4. With a scar in the uterus or cervix or any gynaecological anomaly detected with ultrasound
5. A history or evidence of mitral stenosis, glaucoma, or sickle cell anaemia
6. Diastolic blood pressure greater than 90 mmHg
7. Uncontrolled bronchial asthma
8. Systolic blood pressure less than 90 mmHg
9. History or evidence of thromboembolism or liver disease
10. Presence of an intrauterine device in utero
11. Haemolytic disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness, induction to abortion interval, side effects and acceptability.<br><br>Approximate duration of involvement in the study for each subject: first follow-up at 15 days post-treatment, second follow-up (if required) at 42 days, subsequent follow-up as needed.
- Secondary Outcome Measures
Name Time Method o secondary outcome measures