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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	7 November 2022
Main ID:	ISRCTN24130607
Date of registration:	01/04/2004
Prospective Registration:	No
Primary sponsor:	UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Public title:	Comparison of two mifepristone doses and two misoprostol intervals for early pregnancy termination
Scientific title:	Comparison of two mifepristone doses and two misoprostol intervals for early pregnancy termination
Date of first enrolment:	01/12/2001
Target sample size:	1500
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN24130607
Study type:	Interventional
Study design:	Randomised controlled trial (Treatment)
Phase:	Not Applicable

Countries of recruitment
Bosnia and Herzegovina	China	Croatia	Hungary	Macedonia	Mongolia	Montenegro	Romania
Serbia	Slovenia	South Africa	Sweden	Switzerland	Viet Nam	Zambia

Contacts

Name:	Helena von Hertzen
Address:	World Health Organization 20 Avenue Appia CH-1211 Geneva-27 Switzerland
Telephone:	-
Email:	vonhertzenh@who.int
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Induced abortion
Pregnancy and Childbirth
Abortion

Intervention(s)

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(s)

1. Effectiveness to induce complete abortion in relation to length of amenorrhoea
2. Side effects
3. Duration of bleeding

Secondary Outcome(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

Secondary ID(s)

WHO/ HRP ID A15078

Source(s) of Monetary Support

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)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

1. SERG - Scientific and Ethical Review Group at WHO 2. SCRIHS - Scientific Committee on Research in Human Subjects

Results

Results available:	Yes
Date Posted:
Date Completed:	01/12/2002
URL:

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