Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
A15066
Study information
Scientific title
Acronym
Cervical priming prior to VA
Study hypothesis
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
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
Study design
Randomised placebo-controlled multicentre clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
21/10/2002
Overall trial end date
24/09/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
4984
Participant 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
Recruitment start date
21/10/2002
Recruitment end date
24/09/2005
Locations
Countries of recruitment
Armenia, China, Cuba, Hungary, India, Mongolia, Romania, Slovenia, Viet Nam
Trial participating centre
Department of Reproductive Health and Research
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Sponsor details
Department of Reproductive Health and Research
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list