Hassan 2014.
Methods | 2‐arm RCT | |
Participants | Setting: large Governmental hospital, Saudi Arabia. February 2009‐March 2013 Inclusion criteria: women with a previous CS, a live singleton fetus (37‐42 weeks of gestation) in cephalic presentation and a reactive non‐stress test, BS of ≤ 7 before onset of labour, no spontaneous contractions (< 4 contractions within 20 min) Exclusion criteria: women in active labour or with uterine surgery other than lower segment CS, ruptured membranes, chorioamnionitis, antepartum haemorrhage, contraindication to prostaglandins use (e.g. bronchial asthma or glaucoma), contraindication to vaginal delivery, nonvertex presentation, multiple pregnancy, major fetal anomalies or demise |
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Interventions | Experimental intervention: single dose of dinoprostone 10 mg sustained‐release vaginal pessary (Propess; controlled Therapeutics (Scotlantd) Ltd., East Kilbride, UK) into the posterior vaginal fornix. The dinoprostone pessary releases at a steady rate (0.3 mg/h). It remained in the vagina for up to 24 h, as recommended by the manufacturer. It was removed if it was still present 24 h after placement, if a worrisome fetal heart rate pattern persisted, or if the woman had efficient uterine contractions (3‐4 contractions in 10 min). Total number randomised: n = 100 Comparison intervention: 1.5 mg dinoprostone vaginal tablet (Prostin E2; Parmacia & Upjohn, Puurs, Belgium) into the posterior vaginal fornix for a maximum of 3 doses with 6‐hourly intervals between each dose. Before application of each dose, vaginal examination to ascertain the BS and CTG was performed to assess fetal well‐being and frequency of uterine contractions. Total number randomised: n = 100 |
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Outcomes | Primary outcome: vaginal delivery rate. Secondary outcomes: induction to delivery time, maternal satisfaction score for the birth process obtained within 24 h of delivery (a VAS of 0‐10, with a greater score denoting better satisfaction), maternal and neonatal complications | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Women included in this study were randomly allocated into two equal groups”, no description of random sequence generation |
Allocation concealment (selection bias) | Unclear risk | No allocation concealment described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | “The study was open labelled; thus, women and clinicians were aware of the treatment allocation scheme.” |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Open‐label study, no mention of blinding outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All women appear to be accounted for |
Selective reporting (reporting bias) | Low risk | Assessed from published report with no protocol available, however outcomes were comprehensively reported |
Other bias | Low risk | Analysis was done by ITT. Baseline characteristics, including indications for labour induction, were similar between groups |