Medical abortion at 10-20 weeks
| ISRCTN | ISRCTN49711898 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49711898 |
| EudraCT/CTIS number | 2013-004294-27 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/08/2013
- Registration date
- 02/10/2013
- Last edited
- 17/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
46 Route de Montfleury
Geneva
1214
Switzerland
Study information
| Study design | International multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Termination Of Pregnancy at 64-140 days |
| Study acronym | TOP |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2014 |
| Completion date | 30/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 600-670 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 30/06/2015 |
Locations
Countries of recruitment
- India
- Sweden
- Switzerland
- Thailand
- Viet Nam
Study participating centre
1214
Switzerland
Sponsor information
Charity
46 Route de Montfleury
Geneva
1214
Switzerland
"ROR" |
https://ror.org/039k72k82 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration 2017 poster in http://epostersonline.s3.amazonaws.com/rcog2017/rcog2017.0150066.NORMAL.pdf (added 01/09/2020) |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 03/10/2013 | 17/12/2024 | No | No |
Additional files
Editorial Notes
17/12/2024: Uploaded protocol (not peer-reviewed) as an additional file.
01/09/2020: No publications found. EudraCT number and poster link added.
