Sheikher 2009.
Methods | RCT | |
Participants | Inclusion: 1st or 2nd gravida, single, live fetus, cephalic, indication for IOL, GA 37‐42 weeks, BS ≤ 5, absence of uterine contractions. Exclusion: previous uterine surgery, non reassuring FHR tracing, IUGR, oligohydramnios, placenta praevia, multifetal pregnancy, chorioamnionitis, active herpes, EFW > 4 kg, renal or hepatic disease |
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Interventions | 1. Oral misoprostol (n = 30):, 50 mcg, repeated every 4 hours to a max of 5 doses. 2. Vaginal misoprostol (n = 30): 25 mcg, repeated every 4 hours to a max of 5 dosis. n = 30 3. Foley catheter (n = 30): 16 or 18 F, 35 mL. max of 16 hours In all 3 groups after 16 hours oxytocin was started. |
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Outcomes | interval from induction to birth, mode of delivery, maternal complication, neonatal outcome, failed induction | |
Notes | Setting: SMGS hospital, Jammu, India Study period: over 1 year 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) | Unclear risk | Random assigned, no more information reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
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 | No ITT reported, cases missing in table 2, not clear why |
Selective reporting (reporting bias) | High risk | No outcome measures were mentioned in the method section, induction to delivery interval is given but no SDs, |
Other bias | Low risk | No other bias detected |