von Hertzen 2009.
Methods | A computer‐generated randomisation sequence was produced by WHO staff in Geneva to assign participants within each centre to sublingual or vaginal treatment group by randomly permuted blocks with a fixed block size of six. Allocation was concealed by using sealed, opaque, sequentially numbered envelopes, which were filled and labelled in accordance with the list of randomization for each centre by Magistra, Geneva, Switzerland. | |
Participants | 681 pregnant women (group I: 340, group II: 341) Inclusion criteria: healthy, older than the age of legal consent, had a single intrauterine pregnancy of 13–20 weeks (91–140 days) duration as verified by ultrasound and had haemoglobin 100 g/l or higher. Exclusion criteria: any indication of serious past or present illness; an allergy to misoprostol; a habit of heavy smoking (.20 cigarettes/day); a scar in the uterus or cervix or any gynaecological anomaly detected with ultrasound; mitral stenosis, glaucoma or sickle cell anaemia; diastolic blood pressure .90 mmHg; uncontrolled bronchial asthma; systolic blood pressure ,90 mmHg; history or evidence of thromboembolism or liver disease; presence of an intrauterine device; or haemolytic disorders. |
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Interventions | Group I: 400 μg misoprostol vaginally, 2 placebo tablets sublingually, every 3 hours up to five doses until abortion took place. Group II: 400 μg misoprostol sublingually, 2 placebo tablets vaginally, every 3 hours up to five doses until abortion took place. Placebo tablets were manufactured by Labatec, Geneva, Switzerland; similar shape and colour as misoprostol tablets. The blisters were labelled indicating which tablets were to be taken sublingually and which tablets vaginally. Additional misoprostol tablets were provided to the centres to be used sublingually for those women who did not abort within 24 h. After expulsion of the fetus, one additional dose of the tablets was administered. |
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Outcomes | Primary outcome: successful abortion (including complete and incomplete abortion) within 24 h. Secondary outcome: successful abortion within 48 h induction‐to‐abortion interval (the start of treatment to expulsion of fetus, side effects and women’s perceptions of the method. |
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Notes | Definition of abortion: complete or incomplete abortion, while treatment failures included missed abortion, continuing pregnancy and undetermined outcomes. Ten women received a blood transfusion and three women required hospitalization after discharge, two of them for surgical evacuation of the uterus and one for reasons unrelated to the study. After abortion, the products of gestation were examined to see whether the abortion was complete. If necessary, or if it was a local routine practice (three centres), exploration and evacuation of the uterus was performed. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ adequate |
Blinding? All outcomes | Low risk | |
Free of other bias? | Low risk | A stratified analysis was conducted by parity because there was a highly significant interaction of treatment by parity. No apparent differences between the groups in terms of maternal age and gestational age. |