Skip to main content
. 2019 Oct 18;2019(10):CD001233. doi: 10.1002/14651858.CD001233.pub3

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
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
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
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