Caesarean Section Following Induction of Labour in Nulliparous Women with an Unfavourable Cervix: a Comparison of Three Ripening Agents - PGE2 Gel, Single or Double Balloon Catheter

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One quarter of labours are induced due to either maternal or fetal reasons in the Western World. Unfortunately, not all of these inductions are successful, and a failed induction of labour usually results in a caesarean section. The most useful predictor of success for an induction of labour is the assessment of the cervix (neck of womb) prior to the induction of labour. A firm, closed cervix (unfavourable cervix) increases the likelihood of a failed induction of labour and a caesarean section. A number of different techniques have been utilised to improve the success rates of induction of labour when the cervix is unfavourable. These include hormone infusions (oxytocin), intravaginal gels and tablets (prostaglandin E2, misoprostol) and mechanical techniques for ripening cervixes. With an unfavourable cervix, the caesarean section rate with hormone infusions is 50%. The use of intravaginal prostaglandin E2 reduces the caesarean section rate to 30%, and this is currently the routine technique for induction of labour when the cervix is unfavourable. Mechanical ripening of the cervix with balloon catheters has been investigated over the last 10 years using both single and double balloon catheters. The single balloon catheter has been found to be at least as effective as prostaglandin E2 vaginal gel. Several small clinical trials have suggested that a double balloon catheter may be more effective at cervical ripening and induction of labour, lowering the caesarean section rate for failed induction of labour. The specific aim of this project is to compare the standard induction of labour technique utilised for women with an unfavourable (closed, tight) cervix, which is intravaginal prostaglandin E2, with induction of labour with the single balloon Foley catheter and with a double balloon catheter. It is hypothesised that the double balloon catheter will be more effective at cervical ripening than prostaglandin E2 or the Foley single balloon catheter, reducing the number of caesarean sections for failed induction of labour without increasing the number of caesarean sections for non-reassuring fetal heart rate patterns. In this trial, we plan to recruit 330 women who deliver at King Edward Memorial Hospital, and to randomise them to one of three groups Group 1: Standard induction of labour with vaginal prostaglandin E2 Group 2: Induction of labour with the single balloon Foley catheter Group 3: Induction of labour with the ARD double balloon catheter The potential significance of this trial is that we hope to prove that the new double balloon catheter technique will reduce the caesarean section rate in women who are having an induction of labour from 30% with the standard induction of labour technique, to 15% with the new technique. Reducing the caesarean rate has short, intermediate, and long-term benefits. The short-term benefits include reduced operative morbidity and shorter hospital stay. The intermediate benefits include improved maternal wellbeing during the first month post delivery by avoiding a major abdominal operation. The long term benefits include easier options with subsequent pregnancy as labour is less complicated if the mother has not had a previous caesarean section. Avoiding caesarean sections also reduces the incidence of low-lying placentas and placentas which grow into previous uterine scars which increases the risk of hysterectomy with subsequent pregnancies.

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