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

Kandil 2012.

Study characteristics
Methods Prospective quasi‐RCT
Participants Inclusion criteria: 41 weeks or more, primigravida, BS < 4, singleton living fetus, vertex presentation, no evidence of active labour, a reassuring FHR pattern, no evidence of intrauterine infection. 
Exclusion criteria: contra‐indication for vaginal delivery, previous uterine surgery, non‐reassuring FHR, IUFD, ruptured membranes, vaginal infection, malpresentation, macrosomic fetus, cephalopelvic disproportion, history of APH, contra‐indication to PGs
Interventions 1. 18F Foley catheter, 30 cc sterile saline. Taped to the inner thigh. Each patient received 1 g of ampicillin/6 hours. Removed after 12 hours. (N = 50)
2. 25 ug misoprostol vaginally every 4 hours (N = 50)
Outcomes Induction to delivery time, oxytocin use, route of delivery, occurrence of chorioamnionitis, AS, admission to NICU, tachysystole, hypertonus, hyperstimulation
Notes 9 patients were insertion of Foley was not possible were replaced by 9 other patients!
Setting: Menofyia University Hospital, Egypt
Study period: from January 2010 to October 2010
Funding: not reported
Declarations of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Randomisation by odd or even admission date
Allocation concealment (selection bias) High risk Randomisation by odd or even admission date
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 ITT was not mentioned. 9 patients in Foley group were replaced by 9 others because insertion of Foley was not possible. No flow chart, no description of lost to follow‐up.
Selective reporting (reporting bias) Low risk All pre‐described outcome measures were mentioned.
Other bias Low risk No other bias detected