Khamaiseh 2012.
Methods | RCT | |
Participants | Inclusion criteria: age 15 years or more, term, singleton, live fetus in vertex presentation, intact membranes and BS < 6. Exclusion criteria: previous CS or history of other uterine surgery, history of ante partum haemorrhage, cephalopelvic disproportion, acute fetal distress revealed by a non stress test prior to induction, signs of infection, ruptured membranes, EFW > 4300, or known allergy to PG |
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Interventions | PG E2 (n = 204) tablets 3 mg, max 2 dose. AROM performed if labour did not commence after 2 doses Foley catheter (n = 210): 22/24F, 50‐60 mL in balloon.Removed after 24 hours and AROM if possible |
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Outcomes | Mode of delivery, time interval between the start of induction and delivery, oxytocin requirement, the indications for CS and adverse neonatal and maternal reactions to the cervical ripening agent. Hyperstimulation with and without FHR changes, failed induction. | |
Notes | Setting: King Hussein Medical Centre and Prince Ali Bin Al‐Hussein hospital, Jordan Study period: July 2009 ‐ July 2010 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) | Low risk | Random sequence generated by computer |
Allocation concealment (selection bias) | Unclear risk | Not described, only description: Randomisation was done by a computer‐generated list of random numbers |
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 | Unclear risk | ITT analysis not reported and not clear if used, 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 |