Condition category
Pregnancy and Childbirth
Date applied
17/04/2007
Date assigned
03/05/2007
Last edited
10/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helena von Hertzen

ORCID ID

Contact details

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

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 measures

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

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes