Methods | RCT. | |
Participants | Setting: 102 women in a Cairo hospital, Egypt. Inclusion criteria: women at term (> 37 weeks’ gestation) scheduled for induction, singleton viable fetus, intact membranes, no uterine contractions Exclusion criteria: malpresentation, placenta previa, previous uterine surgery, contraindications to induction |
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Interventions | Intervention group: self-administered IMN, 40 mg, 3 doses 12 hrs apart (scheduled for 36, 24 and 12 hrs before induction Comparison group: placebo same regiment as intervention group |
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Outcomes | CS, further induction agents required, PPH, Apgar score >7 at 5mins, NICU admission, side effects | |
Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Computer generated sequence. |
Allocation concealment? | Yes | Coded treatment packs prepared by pharmacy. |
Blinding? Women |
Yes | Placebo controlled trial. |
Blinding? Clinical staff |
Yes | |
Incomplete outcome data addressed? All outcomes |
Yes | All women randomised appear to be accounted for in the analysis |