Condition category
Pregnancy and Childbirth
Date applied
04/05/2006
Date assigned
04/05/2006
Last edited
25/08/2011
Prospective/Retrospective
Prospectively 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

Department of Reproductive Health and Research
World Health Organization
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 3373
vonhertzenh@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A35148

Study information

Scientific title

Acronym

Study hypothesis

Our hypothesis is that the efficacy of the 0.4 mg dose of misoprostol, whether given sublingually or vaginally after mifepristone pre-treatment, is not inferior to that of the 0.8 mg dose of misoprostol within a margin of 3%.

Ethics approval

Ethics approval received on the 24th May 2005.

Study design

A randomised, placebo-controlled, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Termination of early pregnancy

Intervention

200 mg mifepristone orally on Day 1 of the study followed 36 - 48 hours later by:
1. Four placebo tablets vaginally and two tablets of 0.2 mg misoprostol sublingually followed by two placebo tablets sublingually 20 minutes later
2. Four placebo tablets vaginally and two tablets of 0.2 mg misoprostol sublingually followed by another two sublingual misoprostol tablets of 0.2 mg 20 minutes later
3. Two tablets of 0.2 mg of misoprostol and two placebo tablets vaginally and two placebo tablets sublingually followed by another two placebo tablets sublingually 20 minutes later
4. Four tablets of misoprostol vaginally and two tablets of placebo sublingually followed by another two placebo tablets sublingually 20 minutes later

Women return to follow-up visits two weeks and six weeks after mifepristone administration.

Intervention type

Drug

Phase

Not Specified

Drug names

Misoprostol, mifepristone

Primary outcome measures

The four regimens will be compared in respect of the following main outcomes:
1. Their effectiveness to induce complete abortion
2. Induction-to-abortion interval, when possible
3. The occurrence of side-effects
4. Women's perceptions

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2006

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

A total of 2880 subjects (192 women at each of the 15 participating centres) will be recruited from among women requesting legal termination of pregnancy. Participants will satisfy the following criteria:
1. Good general health
2. Older than the age of legal consent
3. Requesting abortion and eligible for legal termination of pregnancy
4. On Day 1 of the study (day of mifepristone administration) the duration of pregnancy not more than 63 days (counted from the first day of the last menstrual period) in a normal 28-day cycle
5. The duration of the pregnancy corresponds to the length of amenorrhoea when verified with ultrasound; if the gestational length according to ultrasound measurements differs more than 4 days, the ultrasound dating should be used
6. The pregnancy is single and intrauterine (single sac)
7. If treatment with misoprostol should fail, agrees to surgical termination of pregnancy
8. Willing and able to participate (return to follow-up!) after the study has been explained
9. Haemoglobin higher than 90 g/l

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2880

Participant exclusion criteria

1. Any indication of serious past or present ill health will be considered a contraindication for recruitment to the study
2. In particular, subjects should not be recruited if any of the following conditions are present:
2.1. Allergy towards mifepristone or misoprostol
2.2. A history or evidence of disorders that represent a contraindication to the use of mifepristone (chronic adrenal failure, known allergy to mifepristone, severe asthma uncontrolled by corticosteroid therapy, inherited porphyria) or prostaglandins (mitral stenosis, sickle cell anaemia, diastolic pressure over 90 mmHg, systolic blood pressure lower than 90 mmHg measured with a traditional instrument)
2.3. A history or evidence of thrombo-embolism, severe or recurrent liver disease
2.4. Has a medical condition or disease that requires special treatment, care or precaution (e.g. corticosteroid or anticoagulant therapy) in conjunction with abortion
2.5. Uterine fibroids are relative contraindication (women with fibroids that are likely to affect bleeding or contractility should be excluded)
2.6. The presence of an intrauterine device (IUD) in utero
2.7. Breastfeeding
2.8. Previous surgery of uterus/uterine cervix is a relative contraindication. However, previous low-segment caesarean section does not need to be a contraindication.
2.9. Suspicion of any pathology of pregnancy (e.g. mola, non-viable pregnancy, threatened abortion)
2.10. In case difficulties are anticipated in the follow-up of the woman (e.g. lives too far)
3. Women older than 35 years can be recruited for the present trial provided they do not smoke, their diastolic blood pressure is less than 90 mmHg and have no known risk factor for cardiovascular disease

Recruitment start date

01/09/2006

Recruitment end date

01/09/2007

Locations

Countries of recruitment

China, Cuba, Georgia, India, Mongolia, Serbia, Slovenia, Viet Nam

Trial participating centre

Department of Reproductive Health and Research
Geneva-27
CH 1211
Switzerland

Sponsor information

Organisation

UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction

Sponsor details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 3373
vonhertzenh@who.in

Sponsor type

Research organisation

Website

http://www.who.int

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

Publication citations

Additional files

Editorial Notes