Somirathne 2017.
| Study characteristics | ||
| Methods | RCT | |
| Participants | Inclusion criteria: not delivered by 40 weeks + 5 days gestation, having uncomplicated pregnancies with a singleton fetus, longitudinal lie and cephalic presentation. Exclusion criteria were pregnancy‐induced hypertension, gestational diabetes mellitus, multiple pregnancies, planned CS, fetal growth restriction and scarred uterus |
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| Interventions | 1. Foley catheter, (n = 89), 60 mL, max 24 hours 2. Low dose oral misoprostol (n = 91), 50 mcg, 3 gifts, 4 hourly (N = 91) In both groups, if cervix is unfavourable after 24 hours Foley group PGE2, oral misoprostol group Foley catheter) |
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| Outcomes | The induction delivery interval following IOL, the mode of delivery, the reasons for operative delivery, maternal morbidity, hyperstimulation, uterine rupture, peripartum hysterectomy, postpartum blood transfusion or crystalloid transfusion, IV antibiotics, maternal pyrexia of > 38°C, fetal and neonatal outcome and morbidity, suspicious or pathological CTG according NICE guidelines, meconium‐stained liquor, birthweight, 1 minute AS, NICU and reason for admission | |
| Notes | Setting: University Unit of the THMG, Sri Lanka Study period: September 2014 to April 2015. Funding: none Declarations of interest: none declared |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated numbers, block randomisation,stratified by parity |
| Allocation concealment (selection bias) | Low risk | Sequentially‐numbered, sealed, opaque envelopes |
| 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 not reported, no missing data or cases. referred to Figure 1, but not available |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported in results |
| Other bias | Low risk | No other bias detected |