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 measure
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 (if study stopped)
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
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
2004 results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15198763
Publication citations
-
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.