Methods | RCT 2-arm parallel group design. | |
Participants | 84 women attending a USA hospital between 199 to 2001. Inclusion criteria: singleton, cephalic presentation, intact membranes, Bishop score of 6 or less, reactive NST Exclusion criteria: ruptured membranes, Bishop score > 6, contraindication to induction, > 3 contractions in 10 min, uterine scar |
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Interventions | Intervention group: vaginal misoprostol 25 mcg. Comparison group: intracervical PGE2 gel (dinoprostone) 0.5 mg Women in both groups were randomised after a reactive NST. After drug administration women had continuous fetal heart rate monitoring for 3hrs with discharge home if clinically stable. Women were asked to return the next day (after 18 hrs) for oxytocin induction if labour was not established |
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Outcomes | Vaginal delivery within 24 or 48 hrs, uterine hyperstimulation, CS, oxytocin required, Apgar score < 7 at 5 min, NICU admission | |
Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Random number table. |
Allocation concealment? | Yes | Opaque sequentially numbered envelopes (not stated whether sealed) |
Blinding? Women |
No | Blinding women would be feasible but the study was not blinded |
Blinding? Clinical staff |
No | |
Blinding? Outcome assessor |
No | |
Incomplete outcome data addressed? All outcomes |
Yes | 84 women were randomised (42 in each group), 2 women were lost to follow up in the misoprostol group but were included in the denominators |
Free of other bias? | Yes | None apparent. |