Kandil 2012.
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) |
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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 |
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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 |