Tita 2006.
Methods | RCT | |
Participants | Inclusion: preterm rupture of membranes, cervix ≤ 2 cm GA ≥ 34 weeks, singleton gestation, cephalic, Exclusion: regular uterine contractions (contractions more frequent than every 5 minutes), 2 prior transverse uterine incisions/vertical uterine incision/transmural myomectomy or any obstetric contraindication to labour, evidence of chorioamnionitis, lethal fetal anomalies, intrauterine fetal demise, placenta previa, suspected abruption/significant haemorrhage, non‐reassuring FHR pattern |
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Interventions | Foley + oxytocin (n = 87) oxytocin only (n = 82) |
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Outcomes | Reported outcomes: hours from placement of Foley or initiation of oxytocin to delivery, rate of delivery (vaginal or caesarean) within 24 hours caesarean rate, induction to vaginal delivery interval. | |
Notes | Grey literature: study terminated, primary outcomes reported in trial registration. Setting; USA Study period: December 2005 ‐ May 2008 Funding: not reported Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation process unclear |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not feasible due to nature of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Unclear if ITT analyses was used. for CS there are missing cases |
Selective reporting (reporting bias) | High risk | Only primary outcomes were reported in trial registration |
Other bias | Unclear risk | Study was terminated (not clear why) |