Comparison of two doses and two routes of administration of misoprostol after pre-treatment with mifepristone for early pregnancy termination: a randomised, placebo-controlled, multicentre trial
| ISRCTN | ISRCTN87811512 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87811512 |
| Secondary identifying numbers | A35148 |
- Submission date
- 04/05/2006
- Registration date
- 04/05/2006
- Last edited
- 27/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helena von Hertzen
Scientific
Scientific
Department of Reproductive Health and Research
World Health Organization
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
| Phone | +41 (0)22 791 3373 |
|---|---|
| vonhertzenh@who.int |
Study information
| Study design | A randomised, placebo-controlled, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Comparison of two doses and two routes of administration of misoprostol after pre-treatment with mifepristone for early pregnancy termination: a randomised, placebo-controlled, multicentre trial |
| Study objectives | 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(s) | Ethics approval received on the 24th May 2005. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Misoprostol, mifepristone |
| Primary outcome measure | 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 study start date | 01/09/2006 |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 2880 |
| Total final enrolment | 3005 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- China
- Cuba
- Georgia
- India
- Mongolia
- Serbia
- Slovenia
- Switzerland
- Viet Nam
Study participating centre
Department of Reproductive Health and Research
Geneva-27
CH 1211
Switzerland
CH 1211
Switzerland
Sponsor information
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Research organisation
Research organisation
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
| Phone | +41 (0)22 791 3373 |
|---|---|
| vonhertzenh@who.in | |
| Website | http://www.who.int |
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
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)
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 |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/06/2008 | 06/01/2021 | Yes | No |
| Results article | 01/09/2010 | 27/10/2022 | Yes | No |
Editorial Notes
27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
06/01/2021: Publication reference added.
