Soliman 2013.
Methods | A prospective double‐blind randomised clinical trial conducted in Tanta University Hospital, Egypt between April 2010 and March 2012. | |
Participants | 196 women participated in this study. Inclusion criteria: nulliparous women, gestational age of at least 37 weeks, with singleton fetus and vertex presentation, Bishop score less than 6 and intact membranes, reactive non‐stress test, normal umbilical artery doppler indices, absence of labour and willingness to participate were included in the study. Exclusion criteria: women excluded from study were multiparous, with multiple pregnancy, fetal malpresentation, premature rupture of membranes, regular uterine contractions, major cephalopelvic disproportion and with contraindications to ISMN or misoprostol. |
|
Interventions | 200 women were randomised into 3 groups and 196 women were analysed. 4 dropouts noted, 2 each in ISMN and misoprostol group as they did not meet the inclusion criteria. 65 women received 50 mcg of misoprostol vaginally. 65 women received 40 mg ISMN and 66 women had both 40 mg ISMN and 50 mcg misoprostol. 3 doses of the medication was inserted vaginally at 0, 6 and 12 hours. |
|
Outcomes |
Maternal: caesarean section, uterine hyperstimulation without FHR changes, oxytocin augmentation, epidural analgesia, analgesia required, nausea and vomiting, headache and postpartum haemorrhage. Fetal: meconium‐stained liquor, Apgar score less than 7 in 5 minutes and NICU admission. |
|
Notes | In this review we have not used the combination treatment data because it is a complex intervention. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence used for randomisation. |
Allocation concealment (selection bias) | Low risk | Sealed, opaque and sequentially numbered envelopes were used. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence to the contrary. |
Selective reporting (reporting bias) | Low risk | No evidence to the contrary. |
Other bias | Unclear risk | Unclear. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Patient and therapist were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear. |