Carbone 2013.
Methods | RCT | |
Participants | Inclusion: singleton, viable gestation (≥ 24 weeks), cephalic, intact membranes, BS < 7 Exclusion: malpresentation, multifetal gestation, spontaneous labour, contraindication to PGs, fetal growth restriction, anomalous fetus, fetal demise, previous CS, or other uterine surgery. |
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Interventions | Foley + misoprostol (n = 56): 25 mcg vaginal misoprostol every 4 hours AND Foley catheter filled with 60 mL saline; taped to the inner thigh under gentle traction. misoprostol alone (n = 61): 25 mcg vaginal misoprostol every 4 hours Not mentioned for how long misoprostol and/or Foley was given in total. |
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Outcomes | Induction to delivery time, mode of delivery, tachysystole, postpartum haemorrhage (> 500 cc), chorioamnionitis, neonatal AS and NICU admission. | |
Notes | Setting: USA Study period: January 2011 to April 2012 Funding: not reported Declarations of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence |
Allocation concealment (selection bias) | Low risk | Opaque envelopes, not stated if these were sequential numbered |
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 | Low risk | ITT, no missing data or cases |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported in results |
Other bias | Low risk | No other bias detected |