Comparison of two routes and two intervals of administration of misoprostol for the termination of early pregnancy: a randomised multicentre trial

ISRCTN	ISRCTN10531821
DOI	https://doi.org/10.1186/ISRCTN10531821
Protocol serial number	WHO/HRP ID A05217
Sponsor	UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
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 investigate the feasibility of the misoprostol-only regimen (0.8 mg vaginally or sublingually every 3 hours versus every 12 hours up to three doses).
Ethics approval(s)	Institutional review boards at all participating hospitals and the World Health Organization (WHO) Secretariat Committee on Research on Human Subjects gave ethics approval.
Health condition(s) or problem(s) studied	Induced abortion
Intervention	Four treatment groups: A: Sublingual misoprostol every 3 hours B: Sublingual misoprostol every 12 hours C: Vaginal misoprostol every 3 hours D: Vaginal misoprostol every 12 hours
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Misoprostol
Primary outcome measure(s)	Effectiveness, induction to abortion interval, side effects and acceptability. Approximate duration of involvement in the study for each subject: first follow-up at 15 days post-treatment, second follow-up (if required) at 42 days, subsequent follow-up as needed.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/12/2002

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	2100
Key inclusion criteria	1. Healthy women, eligible for and requesting medical abortion 2. Agrees to surgical termination should method fail
Key exclusion criteria	1. Any indication of serious past or present illness 2. Allergic to misoprostol or with a strong allergic tendency in general 3. Heavy smokers (greater than 20 cigarettes a day) 4. With a scar in the uterus or cervix or any gynaecological anomaly detected with ultrasound 5. A history or evidence of mitral stenosis, glaucoma, or sickle cell anaemia 6. Diastolic blood pressure greater than 90 mmHg 7. Uncontrolled bronchial asthma 8. Systolic blood pressure less than 90 mmHg 9. History or evidence of thromboembolism or liver disease 10. Presence of an intrauterine device in utero 11. Haemolytic disorders
Date of first enrolment	01/12/2001
Date of final enrolment	01/12/2002

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	09/06/2007		Yes	No
Results article	results	01/06/2012		Yes	No