Condition category
Pregnancy and Childbirth
Date applied
22/03/2004
Date assigned
01/04/2004
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

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
vonhertzenh@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/HRP ID A15066

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Misoprostol

Primary outcome measures

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 trial start date

01/12/2001

Overall trial end date

01/12/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

4464

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/12/2001

Recruitment end date

01/12/2002

Locations

Countries of recruitment

Armenia, China, Cuba, Hungary, India, Mongolia, Romania, Slovenia, Viet Nam

Trial participating centre

World Health Organization
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

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Sponsor type

Research organisation

Website

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

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22405255

Publication citations

  1. Results

    Meirik O, My Huong NT, Piaggio G, Bergel E, von Hertzen H, , Complications of first-trimester abortion by vacuum aspiration after cervical preparation with and without misoprostol: a multicentre randomised trial., Lancet, 2012, 379, 9828, 1817-1824, doi: 10.1016/S0140-6736(11)61937-5.

Additional files

Editorial Notes