Condition category
Pregnancy and Childbirth
Date applied
22/03/2004
Date assigned
01/04/2004
Last edited
10/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helena von Hertzen

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
vonhertzenh@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/ HRP ID A15078

Study information

Scientific title

Acronym

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

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Applicable

Drug names

Mifepristone

Primary outcome measures

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 trial start date

01/12/2001

Overall trial end date

01/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1500

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, Macedonia, Mongolia, Montenegro, Romania, Serbia, Slovenia, South Africa, Sweden, Viet Nam, Zambia

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.who.int/reproductive-health/hrp/

Funders

Funder type

Research organisation

Funder name

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes