Comparison of two mifepristone doses and two misoprostol intervals for early pregnancy terminatio

Not Applicable

Completed

• Conditions: Induced abortion; Pregnancy and Childbirth; Abortion

• Registration Number: ISRCTN24130607
• Lead Sponsor: DP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction

Brief Summary

2009 Results article in https://doi.org/10.1111/j.1471-0528.2008.02034.x (added 27/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2002-12-01
• Study Start: 2004-04-01
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2181

Inclusion Criteria

1. Healthy women
2. Eligible for and requesting medical abortion
3. Agrees to surgical termination should method fail

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified