A double-blind, randomised, controlled multicentre trial of misoprostol treatment prior to Vacuum Aspiration for termination of early pregnancy

ISRCTN	ISRCTN98284169
DOI	https://doi.org/10.1186/ISRCTN98284169
Secondary identifying numbers	A15066

Submission date: 17/04/2007
Registration date: 03/05/2007
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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Helena von Hertzen
Scientific

Department of Reproductive Health and Research
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Study information

Study design	Randomised placebo-controlled multicentre clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	Cervical priming prior to VA
Study objectives	Null hypothesis: There is no difference between first trimester abortion with and without pre-abortion priming of the cervix with 400 micrograms of misoprostol with regard to all complications associated with abortion.
Ethics approval(s)	Approval received from the SCRIHS (Scientific Committee for Research in Human Subjects) and local ethics committees at each participating centre. SCRIHS approved the protocol of this Project A15066 on 23/07/2001
Health condition(s) or problem(s) studied	Termination of early pregnancy by vacuum aspiration
Intervention	Two tablets of 200 micrograms of misoprostol or two placebo tablets will be administered vaginally three hours before vacuum aspiration. Type of analgesia/anaesthesia, baseline cervical dilation, duration of procedure, amount of bleeding, complications during and after procedure, etc., will be recorded. A follow-up visit is scheduled 7 to 10 days after vacuum aspiration.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Misoprostol
Primary outcome measure	Complication rates in misoprostol and placebo groups, measured during the procedure, in the immediate post-operative period, and up until the follow-up visit 7 to 14 days after the procedure
Secondary outcome measures	1. Ease of the procedure (dilation, duration of procedure, pain level), measured during the procedure 2. Side-effects, measured at any time after administration of misoprostol until the end of the study
Overall study start date	21/10/2002
Completion date	24/09/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	4984
Key inclusion criteria	1. Women requesting abortion and eligible for legal termination of normal single intrauterine pregnancy of less than 12 completed weeks (84 days) of gestation 2. Consent to participation 3. Able to understand information on the study 4. Agree to return for the scheduled follow-up visit
Key exclusion criteria	Women are not eligible if they have: 1. A medical condition or disease that requires special treatment, care of precautions in conjunction with vacuum aspiration 2. Allergy to misoprostol 3. Contraindications to misoprostol 4. Anaemia or any coagulation disorder
Date of first enrolment	21/10/2002
Date of final enrolment	24/09/2005

Locations

Countries of recruitment

Armenia
China
Cuba
Hungary
India
Mongolia
Romania
Slovenia
Switzerland
Viet Nam

Study participating centre

Department of Reproductive Health and Research

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

Department of Reproductive Health and Research
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Website	http://www.who.int/reproductive-health/hrp/index.htm
"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