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
Protocol serial number	WHO/HRP ID 97903
Sponsor	UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)
Funder	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)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Helena von Hertzen
Scientific

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

Email	vonhertzenh@who.int

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Misoprostol, mifepristone
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/12/2000

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

World Health Organization

Geneva-27
CH-1211
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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