025 Haghighi 2006.
Methods | Randomised trial. Allocation concealment made by sequential sealed opaque envelope. | |
Participants | Inclusion criteria: women with singleton pregnancy, gestational age from 29 to 36 weeks, PPROM, parity of 2 or less, Bishop score ≤ 4, Normal FHR reactivity, absence of uterine contractions and vertex presentation. Exclusion criteria: previous uterine scar, fetal growth retardation, pre‐eclampsia, evidence of cephalopelvic disproportion, chorioamnionitis and contraindication of prostaglandin treatment. |
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Interventions | The intervention group received 1 25 mcg dose of misoprostol. If the contractions were not adequate in 3 hours, oxytocin augmentation was started. The comparison group received oxytocin infusion (started with 2 mcU/min and increased every 15 minutes until adequate uterine contraction). | |
Outcomes | There was a statistically significant difference in the interval between admittance and vaginal delivery (507.68 min ± 248.01 min in the misoprostol group vs 596.66 min ± 246.38 min in the control group; P < .005) and also in the incidence of caesarean section due to failed labour induction (9.2% in the misoprostol group vs 18.5% in the control group). | |
Notes | Akbarabadi Hospital in Tehran, Iran. The study run from December 2002 to May 2004. The numbers of baseline data and the neonatal outcomes were not stated. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Adequate |
Allocation concealment (selection bias) | Low risk | Adequate |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear |
Incomplete outcome data (attrition bias) All outcomes | High risk | Adequate |
Selective reporting (reporting bias) | High risk | Inadequate |
Other bias | High risk | Inadequate |