Methods | RCT, 2-arm trial. | |
Participants | Setting: 43 women attending antenatal clinics in California, USA Inclusion criteria: women with “post-dates” pregnancies (gestational age > 41 weeks and 6 days based on reliable menstrual history and early ultrasound confirmation) with reactive NST Exclusion criteria: contraindications to prostaglandins. |
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Interventions | Intervention group: intracervical PGE2 0.5 mg. Comparison group: visually identical placebo gel. Women in both groups were observed for 1 hr with external fetal monitoring and then discharged home |
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Outcomes | Bishop score on admission, mode of delivery, interval to delivery, length of labour, infant birthweight and Apgar score | |
Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | External sequence generation by hospital pharmacy. |
Allocation concealment? | Yes | Coded syringes of identical appearance were dispensed from pharmacy |
Blinding? Women |
Yes | Placebo controlled trial. |
Blinding? Clinical staff |
Yes | |
Blinding? Outcome assessor |
Unclear | Not clear when code was revealed. |
Incomplete outcome data addressed? All outcomes |
Yes | All women randomised appeared to be included in the analyses |
Free of other bias? | Yes | No other bias apparent. |