Condition category
Pregnancy and Childbirth
Date applied
22/08/2013
Date assigned
02/10/2013
Last edited
06/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Helena von Hertzen

ORCID ID

Contact details

46 Route de Montfleury
Geneva
1214
Switzerland

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 measures

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

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

Sponsor information

Organisation

Concept Foundation (Switzerland)

Sponsor details

46 Route de Montfleury
Geneva
1214
Switzerland

Sponsor type

Charity

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes