Pretreatment with vaginal misoprostol before vacuum aspiration

ISRCTN	ISRCTN85366519
DOI	https://doi.org/10.1186/ISRCTN85366519
Secondary identifying numbers	WHO/HRP ID A15066

Submission date: 22/03/2004
Registration date: 01/04/2004
Last edited: 10/10/2014

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
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	To evaluate if vaginal administration of 0.4 mg misoprostol facilitates cervical dilation, reduces complications of first trimester induced abortion, and is acceptable to women.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Induced abortion
Intervention	Misoprostol (0.4 mg) versus placebo tablet three hours before vacuum aspiration. Approximate duration of involvement in the study for each subject is one follow up visit ten days post-treatment.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Misoprostol
Primary outcome measure	Will evaluate if preoperative treatment with 0.4 mg misoprostol administered vaginally three hours before vacuum aspiration can reduce complications of surgical first trimester abortion.
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/12/2001
Completion date	01/12/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	4464
Key inclusion criteria	1. Pregnancy of less than 12 completed weeks 2. Be informed about the study and sign a consent form 3. Agree to return for a follow-up visit five to ten days after surgery
Key exclusion criteria	No exclusion criteria
Date of first enrolment	01/12/2001
Date of final enrolment	01/12/2002

Locations

Countries of recruitment

Armenia
China
Cuba
Hungary
India
Mongolia
Romania
Slovenia
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
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	12/05/2012		Yes	No