A double-blind, randomised, controlled multicentre trial of three misoprostol regimens after pretreatment with mifepristone for termination of early pregnancy

ISRCTN	ISRCTN81170837
DOI	https://doi.org/10.1186/ISRCTN81170837
Secondary identifying numbers	WHO/HRP ID 97903

Submission date: 19/03/2004
Registration date: 01/04/2004
Last edited: 31/05/2011

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 of protocol

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
Study objectives	To compare three treatment regimens of misoprostol when used after pretreatment with mifepristone for the termination of early pregnancy in women with the length of amenorrhoea of up to 63 days.
Ethics approval(s)	Ethics approval received for all centres before participant recruitment.
Health condition(s) or problem(s) studied	Induced abortion
Intervention	All women treated with a single dose of 200 mg mifepristone on Day 1. Day 3: Group A: 0.8 mg misoprostol orally and placebo tablets vaginally. Groups B and C: 0.8 mg misoprostol vaginally and placebo tablets orally. Groups A and B will continue with 0.4 mg oral misoprostol twice daily on Days 4 - 10. Group C: placebo tablets twice daily on Days 4 - 10.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Misoprostol, mifepristone
Primary outcome measure	Three treatment regimens will be compared in terms of: 1. Their effectiveness to induce complete abortion 2. The frequency of side effects 3. The duration of bleeding Approximate duration of involvement in the study for each subject: second follow-up visit on day 43 post treatment, third follow-up visit if required
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/09/1998
Completion date	01/12/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	2100
Key inclusion criteria	1. Healthy women 2. Eligible for and requesting medical abortion 3. Prepared to terminate the pregnancy should the treatment fail
Key exclusion criteria	No exclusion criteria
Date of first enrolment	01/09/1998
Date of final enrolment	01/12/2000

Locations

Countries of recruitment

China
Finland
Hong Kong
Hungary
India
Mongolia
Norway
Romania
Singapore
Slovenia
Sweden
Switzerland
Viet Nam

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 (HRP)
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2004		Yes	No