Misoprostol administered sublingually for second trimester pregnancy termination

ISRCTN	ISRCTN72965671
DOI	https://doi.org/10.1186/ISRCTN72965671
Secondary identifying numbers	WHO/HRP ID A15065

Submission date: 19/03/2004
Registration date: 01/04/2004
Last edited: 11/12/2008

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
Study hypothesis	To compare two treatment regimens (0.4 mg misoprostol administered sublingually versus vaginally every three hours up to five doses) for the termination of pregnancy in women with a length of amenorrhoea between 14 to 20 weeks.
Ethics approval(s)	Not provided at time of registration
Condition	Induced abortion
Intervention	Misoprostol (0.4 mg) either vaginally or sublingually every three hours up to five doses. Approximate duration of involvement in the study for each subject: first follow up at 15 days post-treatment, another follow-up visit will be carried out according to the practice of the hospital.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Misoprostol
Primary outcome measure	1. The effectiveness to induce complete or partial abortion/induction-to-abortion interval 2. The frequency of side effects 3. Acceptability of treatment to women
Secondary outcome measures	No secondary outcome measures
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	680
Participant inclusion criteria	1. Healthy women 2. Eligible for and requesting legal termination of second trimester pregnancy
Participant exclusion criteria	No exclusion criteria
Recruitment start date	01/12/2001
Recruitment end date	01/12/2002

Locations

Countries of recruitment

Armenia
Georgia
Hungary
India
Slovenia
South Africa
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2004		Yes	No
Results article	results	01/01/2009		Yes	No