Condition category
Pregnancy and Childbirth
Date applied
19/03/2004
Date assigned
01/04/2004
Last edited
31/05/2011
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 97903

Study information

Scientific title

Acronym

Study hypothesis

To compare three treatment regimens of misoprostol when used after pretreatment with mifepristone for the termination of early pregnancy in women with the length of amenorrhoea of up to 63 days.

Ethics approval

Ethics approval received for all centres before participant recruitment.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Induced abortion

Intervention

All women treated with a single dose of 200 mg mifepristone on Day 1.

Day 3:
Group A: 0.8 mg misoprostol orally and placebo tablets vaginally.
Groups B and C: 0.8 mg misoprostol vaginally and placebo tablets orally.

Groups A and B will continue with 0.4 mg oral misoprostol twice daily on Days 4 - 10.
Group C: placebo tablets twice daily on Days 4 - 10.

Intervention type

Drug

Phase

Not Specified

Drug names

Misoprostol, mifepristone

Primary outcome measures

Three treatment regimens will be compared in terms of:
1. Their effectiveness to induce complete abortion
2. The frequency of side effects
3. The duration of bleeding

Approximate duration of involvement in the study for each subject: second follow-up visit on day 43 post treatment, third follow-up visit if required

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/1998

Overall trial end date

01/12/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy women
2. Eligible for and requesting medical abortion
3. Prepared to terminate the pregnancy should the treatment fail

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2100

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/09/1998

Recruitment end date

01/12/2000

Locations

Countries of recruitment

China, Finland, Hong Kong, Hungary, India, Mongolia, Norway, Romania, Singapore, Slovenia, Sweden, 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 (HRP)

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

2004 results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15198763

Publication citations

  1. Results

    Honkanen H, Piaggio G, Hertzen H, Bártfai G, Erdenetungalag R, Gemzell-Danielsson K, Gopalan S, Horga M, Jerve F, Mittal S, Thi Nhu Ngoc N, Peregoudov A, Prasad RN, Pretnar-Darovec A, Shah RS, Song S, Tang OS, Wu SC, , WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion., BJOG, 2004, 111, 7, 715-725, doi: 10.1111/j.1471-0528.2004.00153.x.

Additional files

Editorial Notes