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

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. CONDITION: Termination of early pregnancy ; Pregnancy and Childbirth ; Termination PRIMARY OUTCOME: 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: No secondary outcome measures 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 f