Termination of early pregnancy Pregnancy and Childbirth Termination
Conditions
Interventions
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 p
Sponsors
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
China, Cuba, Georgia, India, Mongolia, Serbia, Slovenia, Switzerland, Viet Nam
Outcome results
None listed