Methods | RCT, 2-arm trial. | |
Participants | Setting: not clear. 68 women included, Inclusion criteria: women with “well-dated” pregnancies with gestational age > 40 weeks and Bishop score < 9 Exclusion criteria: current indication for IOL, malpresentation, multiple pregnancy, previous CS, oligohydramnios (AFI < 5 cm). any contraindication to a trial of labour, current regular contractions |
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Interventions | All women were assessed prior to randomisation. Intervention group: vaginal misoprostol 25 mcg. Comparison group: placebo gel. Fetal and uterine monitoring for 1 hr after treatment then women were discharged home. Labour was induced if BIshop score > 8 after 41 weeks or all women after 42 weeks |
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Outcomes | Uterine hyperstimulation, mode of delivery, epidural, Apgar score, NICU admission. (Women with PROM were given oxytocin to “stimulate labour” but were not included as inductions in the analyses.) | |
Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Computer generated sequence performed in hospital pharmacy. |
Allocation concealment? | Yes | Placebo controlled trial. |
Blinding? Women |
Yes | Placebo of similar appearance. |
Blinding? Clinical staff |
Yes | |
Incomplete outcome data addressed? All outcomes |
Yes | 68 women were randomised, 4 were excluded after randomisation and did not receive the study medication, but were included in an ITT analysis |
Free of other bias? | Unclear | No baseline imbalance apparent. |