Edwards 2014c.
| Methods | RCT | |
| Participants | Inclusion criteria: GA > 36 weeks, live singleton fetus in cephalic presentation, unfavourable cervix (less than 3 cm dilated; if 2 cm dilated, less than 80% effaced). Exclusion criteria: < 18 years, no informed consent in English, > 1 contraction/5 minutes, ruptured membranes, a prior caesarean delivery or any other prior uterine incision, a temperature of 38°C or higher, lethal fetal anomalies, placenta previa, other contraindication to vaginal delivery, suspected placental abruption or undiagnosed bleeding, a category II or III FHR pattern, HIV infection or any other immune dysfunction, an allergy to latex or dinoprostone, previous attempt of cervical ripening. |
|
| Interventions | Foley catheter (n = 185): 16F, 30 mL, minimal tension, removed after 12 hours Dinoprostone vaginal insert (n = 191): removed after 12 hours |
|
| Outcomes | Induction to delivery time, (vaginal) delivery within 12 hours, (vaginal) delivery within 24 hours, tachysystole, clinical chorioamnionitis, endometritis, other postpartum complications, caesarean delivery, early neonatal outcomes | |
| Notes | Setting: multicentre, USA period: July 2010 to February 2013 Funding: not reported Declarations of interest: none declared |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Allocated by an online randomisation system 1 to 1 |
| Allocation concealment (selection bias) | Low risk | Allocation web‐based |
| 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 | Low risk | ITT analyses reported, but women who did not deliver and went home were excluded (5 to 77. Patients with missing values for arterial cord pH level. properly described how this was dealt with |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported in results |
| Other bias | Low risk | No other bias detected |