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. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

Carbone 2013.

Study characteristics
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.
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.
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
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