Plain English Summary
Background and study aims
Two drugs, mifepristone and misoprostol, are authorized to use for the termination of an early pregnancy only, although they are recommended as the best and safest method by the World Health Organization, and also used, unlicensed, for the termination of later stages of pregnancies. Clinical trial data is needed for registration but these data are not currently available. The purpose of this study is to demonstrate how this drug regimen works and how to use the information to officially register the method.
Who can participate?
Women who are 64 to 140 days pregnant can participate in the study.
What does the study involve?
Women will first get a pill of mifepristone to swallow, and when they return to the hospital one or two days later, they will be given the second drug, misoprostol. They may need two to three doses of misoprostol. They are given at 3-hour intervals, before the pregnancy is terminated.
What are the possible benefits and risks of participating?
Some women prefer medical abortion to surgical abortion so this study may give them this choice. Most women in the study can be expected to have a complete abortion and will not be exposed to some of the risks associated with surgical abortion, particularly the risk of physical distress. By participating in the study women do not increase their risks associated with the termination of pregnancy.
Where is the study run from?
The study will be run from eight hospitals in India, Sweden, Thailand and Vietnam.
When is the study starting and how long is it expected to run for?
We expect to start the study by the end of 2013 and it is expected to last for 12-14 months.
Who is funding the study?
Concept Foundation, Geneva, Switzerland.
Who is the main contact?
Dr Helena von Hertzen
helena.vonhertzen@gmail.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Termination Of Pregnancy at 64-140 days
Acronym
TOP
Study hypothesis
Administration of misoprostol 24 h after mifepristone is non-inferior in efficacy, measured as abortion rate at 24 h, to administration of misoprostol 48 h after mifepristone, assuming that this rate in both interval groups will be about 96%-97% and within an inferiority margin of 5%.
Ethics approval
1. Institutional Review Board, Faculty of Medicine, Chulalongkorn University, Thailand, 20/03/2014
2. Committee on Human Rights Related to Research Involving Human Subjects, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand, 22/01/2014
3. Siriraj Institutional Review Board, Thailand, 21/05/2014
Study design
International multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnancy of 64-140 days duration
Intervention
Women are randomized to receive misoprostol treatment (orally) (as in WHO Safe abortion guidelines, 2012) either 24 hours or 48 hours after mifepristone.
Intervention type
Drug
Phase
Not Applicable
Drug names
Misoprostol, Mifepristone
Primary outcome measure
Efficacy (expulsion of pregnancy) at 24 h
Secondary outcome measures
1. Induction-to-abortion interval: This is the time interval from the administration of the first dose of misoprostol until expulsion of the products of conception
2. Possible side-effects: Side effects are recorded during the whole study, from the administration of mifepristone until the follow-up visit, or beyond, if needed
3. Women's perceptions: Women's perception of the method are recorded at an interview during the follow-up visit about two weeks after treatment
Overall trial start date
01/01/2014
Overall trial end date
30/06/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Good general health
2. Older than the age for legal consent
3. Requesting and eligible for legal termination of pregnancy
4. Duration of pregnancy 64-140 days on Day 1 (mifepristone administration), verified by ultrasound
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600-670
Participant exclusion criteria
1. No contra-indications towards mifepristone and misoprostol
2. No serious present or past ill health
3. Molar or extrauterine pregnancy or threathend abortion, >1 low segment C-section
Recruitment start date
01/01/2014
Recruitment end date
30/06/2015
Locations
Countries of recruitment
India, Sweden, Thailand, Viet Nam
Trial participating centre
46 Route de Montfleury
Geneva
1214
Switzerland
Funders
Funder type
Charity
Funder name
Concept Foundation (Switzerland)
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