Induced abortion Pregnancy and Childbirth Abortion
Conditions
Interventions
Four treatment regimens:
1. 100 mg mifepristone followed 24 hours later by misoprostol
2. 100 mg mifepristone followed 48 hours later by misoprostol
3.
Sponsors
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy women 2. Eligible for and requesting medical abortion 3. Agrees to surgical termination should method fail
Exclusion criteria
Exclusion criteria: Any indication of past or present ill health will be considered a contraindication for recruitment to the study. In particular, subjects should not be recruited if any of the following conditions are present: 1. Allergy towards mifepristone or misoprostol 2. A history or evidence of disorders that represent a contraindication to the use of: 2.1. Mifepristone (chronic adrenal failure, known allergy to mifepristone, severe asthma uncontrolled by corticosteroid therapy, inherited porphyria) 2.2. Prostaglandins (mitral stenosis, glaucoma, sickle cell anaemia, diastolic pressure over 90 mmHg, bronchial asthma, systolic blood pressure lower than 90 mmHg) 3. A history or evidence of thrombo-embolism, severe or recurrent liver disease 4. Has a medical condition or disease that requires special treatment, care or precuation (e.g. corticosteroid or anticoagulant therapy) in conjunction with abortion 5. Uterine fibroids are relative contraindication (women with fibroids that are likely to affect bleeding or contractility should be excluded) 6. The presence of an Intra-Uterine Device (IUD) in utero (if IUD can easily be removed from the uterus before administration of mifepristone, subject can be included) breast-feeding previous surgery of uterus/uterine cervix is a relative contraindication In addition, a woman should not be recruited for the study if she is: 7. A heavy smoker (i.e. smoking more than 20 cigarettes daily) or has another risk factor for cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effectiveness to induce complete abortion in relation to length of amenorrhoea 2. Side effects 3. Duration of bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency of side-effects, in particular the occurrence of lower abdominal pain: 1. Nausea, measured between Mifepristone and Misoprostol regimen, within 3 hours after Misoprostol and after Misoprostol up to 1st follow-up visit 2. Vomiting, measured between Mifepristone and Misoprostol regimen, within 3 hours after Misoprostol and after Misoprostol up to 1st follow-up visit 3. Lower Abdominal Pain, measured between Mifepristone and Misoprostol regimen, within 3 hours after Misoprostol and after Misoprostol up to 1st follow-up visit 4. Diarrhoea, measured between Mifepristone and Misoprostol regimen, within 3 hours after Misoprostol and after Misoprostol up to 1st follow-up visit 5. Headache, measured between Mifepristone and Misoprostol regimen, within 3 hours after Misoprostol and after Misoprostol up to 1st follow-up visit 6. Fever, measured within 3 hours after Misoprostol and after Misoprostol up to 1st follow-up visit 7. Chills/shivering, measured within 3 hours after Misoprostol | — |
Countries
Bosnia and Herzegovina, China, Croatia, Hungary, Macedonia, Mongolia, Montenegro, Romania, Serbia, Slovenia, South Africa, Sweden, Switzerland, Viet Nam, Zambia
Outcome results
None listed