Methods | RCT. | |
Participants | Setting: 91 women with prolonged pregnancy (gestational age > 41 weeks) attending a Florida, USA hospital Inclusion criteria: uncomplicated pregnancy, reliable dating, Bishop score < 9, reactive NST and ultrasound Exclusion criteria: vaginal bleeding, ruptured membranes, macrosomia (estimated fetal weight > 4500 g) previous uterine surgery or stillbirth, abnormal FHR or ultrasound, regular contractions |
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Interventions | Intervention group: daily self-administered vaginal PGE2 2mg before bed (women were given instructions re placement and storage of suppositories) Comparison group: self-administered placebo. Telephone contact available 24 hrs per day for both groups. Twice weekly clinic attendance for post-dates surveillance (NST and AFV); induction if indicated or at 44 weeks |
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Outcomes | CS rates, chorioamnionitis, Apgar score at 5 min, NICU admission | |
Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Computer generated. |
Allocation concealment? | Yes | Coded drug boxes. |
Blinding? Women |
Yes | Described as “double blind” placebo controlled. |
Blinding? Clinical staff |
Yes | |
Incomplete outcome data addressed? All outcomes |
Unclear | 91 were enrolled but 11 were lost to follow up (3 were excluded as they were non compliant) |