Culver 2004.
| Methods | RCT, computer‐generated block randomisation 4 and 6, consecutively numbered envelopes. | |
| Participants | Nulliparous women GA 28 or more weeks, BS < 6, intact membranes, singleton, cephalic presentation, Exclusion: previous uterine surgery, non‐reassuring FHR, latex allergy, contraindication to vaginal birth. |
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| Interventions | Foley 30 cc + concurrent oxytocin (83 patients analysed). Misoprostol 25 mcg intravaginally 4‐hourly, oxytocin augmentation after ripening. (79 patients analysed.) |
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| Outcomes | Primary: CS Secondary: tachysystole, hyperstimulation, abnormal FHR tracing, intrapartum and postpartum fever, use of antibiotics, estimated blood loss, blood transfusions, AS, neonatal resuscitation, admission to ICU, meconium aspiration, sepsis, death. |
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| Notes | Power analysis showed 266 patients were to be included, 173 were randomised. Study was stopped because principle investigator moved to other hospital. 11 patients were excluded from analysis, either received other treatment, or incomplete data. Setting: North Caroline Women's hospital and WakeMed hospital, North Carolina, USA Study period: June 1999 to April 2001 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) | Low risk | Computer‐generated sequence. |
| Allocation concealment (selection bias) | Low risk | Consecutively numbered 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 described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 9 patients had incomplete records (4 and 5 in both groups), they were excluded. 2 patients (1 in every group) who did not receive the treatment were excluded, but otherwise ITT. |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcome measures are reported. |
| Other bias | High risk | Recruitment goal was not reached, because PI moved to another institution. |