Ngai 1996.
Methods | Randomisation was by the sealed envelope method. The stratification was by parity (nulliparas, multiparas). | |
Participants | 82 women with a singleton pregnancy at term and prelabour spontaneous rupture of membranes confirmed by speculum examination. All women had a reactive non‐stress test on admission. | |
Interventions | 200 mcg oral misoprostol powder or placebo (vitamin B6). If no response after 12 hours labour was induced with oxytocin. |
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Outcomes | Changes in the BS, need for oxytocin for induction, interval from recruitment to onset of uterine activity and delivery, mode of delivery, neonatal outcome. | |
Notes | 2 women excluded from the primary analysis (one breech and one without baseline cervical assessment). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Stratified randomisation between multipara and nullipara |
Allocation concealment (selection bias) | Low risk | Each patient was given an envelope, chosen according to the stratified randomisation between multiparas and nulliparas |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data for all women reported |
Selective reporting (reporting bias) | Low risk | Selective reporting not apparent |
Other bias | Low risk | None noted |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The envelopes were coded by the hospital pharmacy and the codes were broken only at the end of the study, so that both the medical staff and the patient were blinded to assignment |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessor not described |