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02 September 2010
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| [ Print-friendly version ] |
| Comparison of two mifepristone doses and two misoprostol intervals for early pregnancy termination |
| ISRCTN | ISRCTN24130607 |
| ClinicalTrials.gov identifier | |
| Public title | Comparison of two mifepristone doses and two misoprostol intervals for early pregnancy termination |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | WHO/ HRP ID A15078 |
| Study hypothesis | To compare two doses of mifepristone, 100 mg and 200 mg, followed by 0.8 mg vaginal misoprostol either 24 or 48 hours later in terms of effectiveness, side-effects and duration of bleeding. The objective is to investigate whether the dose of mifepristone can be lowered to 100 mg (double-blind) and whether the interval of 48 hours between mifepristone and misoprostol can be shorted to 24 hours without decreasing efficacy. |
| Ethics approval |
Ethics approval received from:
1. SERG - Scientific and Ethical Review Group at WHO 2. SCRIHS - Scientific Committee on Research in Human Subjects |
| Study design | Randomised controlled trial |
| Countries of recruitment | China, Hungary, Mongolia, Romania, Slovenia, South Africa, Sweden, Viet Nam, Yugoslavia, Zambia |
| Disease/condition/study domain | Induced abortion |
| Participants - inclusion criteria |
1. Healthy women
2. Eligible for and requesting medical abortion 3. Agrees to surgical termination should method fail |
| Participants - 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 |
| Anticipated start date | 01/12/2001 |
| Anticipated end date | 01/12/2002 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1500 |
| 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. 200 mg mifepristone followed 24 hours later by misoprostol 4. 200 mg mifepristone followed 48 hours later by misoprostol All administered vaginally. Approximate duration of involvement in the study for each subject: 43 days (second and last follow-up visit), subsequent follow-up if needed. |
| Primary outcome measure(s) |
1. Effectiveness to induce complete abortion in relation to length of amenorrhoea
2. Side effects 3. Duration of bleeding |
| Secondary outcome measure(s) |
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 |
| Sources of funding | United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP) |
| Trial website | |
| Publications | |
| Contact name | Dr Helena von Hertzen |
| Address |
World Health Organization
20 Avenue Appia |
| City/town | Geneva-27 |
| Zip/Postcode | CH-1211 |
| Country | Switzerland |
| vonhertzenh@who.int | |
| Sponsor | UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction |
| Address |
World Health Organization
20 Avenue Appia |
| City/town | Geneva-27 |
| Zip/Postcode | CH-1211 |
| Country | Switzerland |
| Sponsor website: | http://www.who.int/reproductive-health/hrp/ |
| Date applied | 22/03/2004 |
| Last edited | 01/10/2007 |
| Date ISRCTN assigned | 01/04/2004 |
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