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

ISRCTN	ISRCTN24130607
DOI	https://doi.org/10.1186/ISRCTN24130607
Secondary identifying numbers	WHO/ HRP ID A15078

Submission date: 22/03/2004
Registration date: 01/04/2004
Last edited: 27/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Helena von Hertzen
Scientific

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Email	vonhertzenh@who.int

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Comparison of two mifepristone doses and two misoprostol intervals for early pregnancy termination
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(s)	1. SERG - Scientific and Ethical Review Group at WHO 2. SCRIHS - Scientific Committee on Research in Human Subjects
Condition	Induced abortion
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Mifepristone, misoprostol
Primary outcome measure	1. Effectiveness to induce complete abortion in relation to length of amenorrhoea 2. Side effects 3. Duration of bleeding
Secondary outcome measures	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
Overall study start date	01/12/2001
Overall study end date	01/12/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	1500
Total final enrolment	2181
Participant inclusion criteria	1. Healthy women 2. Eligible for and requesting medical abortion 3. Agrees to surgical termination should method fail
Participant 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
Recruitment start date	01/12/2001
Recruitment end date	01/12/2002

Locations

Countries of recruitment

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

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Sponsor information

UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Research organisation

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Website	http://www.who.int/reproductive-health/hrp/
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Research organisation

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		21/01/2009	27/10/2022	Yes	No

Editorial Notes

27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.