Perry 1998.
Methods | RCT. | |
Participants | Inclusion: singleton gestation, cephalic presentation, BS of ≤ 4. Exclusion: spontaneous uterine contractions, rupture of membranes, placenta previa, unexplained vaginal bleeding, a non‐reactive nonstress test, an EFW > 4500 g, a prior vertical uterine incision, parity of > 5, active genital herpes infection, or a contraindication to receiving PGs |
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Interventions | Vaginal misoprostol 25 mcg every 4 hours (65 women) intracervical Foley of 50cc and PGE2 (4 mg) every 4 hours (62 women) | |
Outcomes | CS, instrumental delivery, uterine hyperstimulation, AS, NICU admission, chorioamnionitis, perinatal death. | |
Notes | Setting: University of Mississippi Medical Center Labor and Delivery Unit, Jackson, USA Study period: August 1996 ‐ April 1997 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 random schedule. |
Allocation concealment (selection bias) | Low risk | The allocation of assignment was concealed by placement in a numbered, opaque, sealed envelope |
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 not reported, although this is likely as numbers are equal to randomised numbers. No missing cases or data in outcomes of interest |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported |
Other bias | Low risk | No other bias detected |