Methods | RCT. 3-arm trial. | |
Participants | Setting: California, USA, women attending a naval medical centre 70 women included in the analysis (2 of 3 treatment arms included, total recruited 105 women) Inclusion criteria: women with “post dates” pregnancy - gestational age 41 weeks confirmed by menstrual dates and pre-20 weeks ultrasound. Uncomplicated pregnancy. Bishop score < 5 Exclusion criteria: women with any contraindication to vaginal delivery |
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Interventions | (1 intervention group had daily membrane stripping; this group has not been included in the analysis in this review.) Intervention group: intracervical PGE2 0.5 mg, daily for 3 days Comparison group: gentle cervical examination, daily for 3 days Women were instructed to return to hospital is they had bleeding, membrane rupture, regular contractions of reduction in fetal movements. Once Bishop score = 8 or women reached 42 weeks they were admitted to hospital for induction |
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Outcomes | Induced at 42 weeks, CS, instrumental delivery. Apgar score < 7 at 5 min, admission to NICU | |
Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Random number tables. |
Allocation concealment? | Yes | Sealed, opaque, sequentially numbered envelopes. |
Blinding? Women |
No | Not feasible. |
Blinding? Clinical staff |
No | |
Blinding? Outcome assessor |
Unclear | Outcome assessment of cervical changes were reported to be blind |
Incomplete outcome data addressed? All outcomes |
Yes | No apparent loss to follow up. |