Randomised trial of intravaginal misoprostol and intracervical Foley catheter for cervical ripening and induction of labour. Comparison of the modified biophysical profile to a "new" biophysical profile incorporating the middle cerebral artery to umbilical artery velocity flow systolic/diastolic ratio.
Induction of labour may be indicated despite an unripe cervix. The purpose of this study was to compare the safety and efficacy of intravaginal misoprostol and an intracervical Foley's balloon catheter for preinduction cervical ripening and labour induction. A total of 120 patients requiring indicated induction of labour with an unfavourable cervix (Bishop's score < or =4) were randomised prospectively to receive either 50 mug intravaginal misoprostol every 6 h for a maximum of two doses, or an intracervical Foley balloon catheter for 12 h followed by an intravenous oxytocin infusion. The two arms of the study were comparable with respect to maternal age, parity, gestational age, indication for induction, and initial Bishop's scores. There were significant change in the Bishop's score in the two groups (5.9 +/- 0.2 and 4.0 +/- 0.2, respectively, p < 0.001) but no inter group differences. Oxytocin induction or augmentation of labour occurred more in the catheter group (95%) than in the misoprostol group (43.3%) (p < 0.0001). Induction to delivery interval was significantly shorter in the misoprostol group than in the catheter group (8.7 +/- 2.4 vs 11.9 +/- 2.7 h p < 0.0001). There was no significant difference noted in the caesarean or other operative delivery rates among patients in the two treatment groups. There was a higher incidence of tachysystole and hyperstimulation in the misoprostol group than in the catheter group (p < 0.03). No differences were observed between groups for meconium passage, 1- or 5-min Apgar scores < 7 and admission into the neonatal intensive care unit. In conclusion, the maternal and perinatal outcomes in this study have shown no difference confirming the efficacy and safety of both methods, however we observe a decrease in the induction-to-delivery interval when misoprostol is used for this purpose. The objective of this study was to determine whether the addition of the middle cerebral to umbilical artery systolic/diastolic velocity waveform ratio to the modified biophysical profile would improve perinatal outcome in patients at high risk.
                A prospective, randomized outcome study of patients referred to the perinatal laboratory for antenatal surveillance was undertaken. Six hundred sixty-five patients were randomized to two antenatal surveillance protocols: group 1, modified biophysical profile; and group 2, modified biophysical profile plus evaluation of the middle cerebral artery to umbilical artery systolic/diastolic ratio. Patients were followed up serially and neonatal outcome data including gestational age at delivery, birth weight, incidence of cesarean section delivery for fetal distress, admission to the neonatal intensive care unit, days in the neonatal intensive care unit, and the presence of significant neonatal morbidity were tabulated.
                The total population showed no statistical difference in outcome parameters between groups 1 and 2. However, a subgroup of patients evaluated for suspected uteroplacental insufficiency did show a significant reduction in caesarean section for fetal distress in group 2 patients.
                In a subgroup of patients at risk for uteroplacental insufficiency, the addition of the middle cerebral/umbilical artery ratio to an antenatal surveillance protocol should be expected to improve perinatal outcome.
On the basis of the evidence available in this review, no specific conclusion can be made regarding the superiority of one catheter class over another. Further adequately powered studies reporting on clinical outcomes (e.g. live birth rate) are required. Additional outcomes such as miscarriage rates and measures of discomfort need to be reported.