PERINATAL TRIALS REPORT

PT0519

Women and the Induction of Labour Dilemma-Trial A

Plain Language Summary:      Between 1998 and 2002, the averaged caesarean section (CS) rate was 27.5%, and the intrapartum CS rate 19.1%. CS rates for those labour spontaneously, induced without the need of prostaglandins, and requiring were 12.3%, 30.5%, and 47.3% resectively. In many reports, CS rates associated with balloon catheters were estimated to be 15%-25%. This low level seems unlikely to be acheivable, given the generally higher rate of CS in our population, and the continued increases in CS rate over the last few years.

The hope that balloon catheters will reduce the CS rate to as low as the ARM grroup also seems unlikely, as an unfavourable cervix near term may possibly indicate a degree of underlying cephalo-pelvic misfit or uterine dysfunction.

Trial status:                         Open to accrual

Date trial opened to accrual:    October 2003

Expected accrual period:         2 years

Trial Objective:

The hypothesis to test is that the use of balloon catheters will lead to a lower CS rate when compared with the use of prostaglandins, to somewhere between the 47.3% associated with prostaglandins and the 30.5% associated with ARM. An arbitrary midpoint of 38% was therefore chosen, as a smaller difference would not be clinically meaningful. Power and sample size calculations were therefore based on an expected difference of 47% and 38%.

Type of administration:        Single centre

Prinicipal Investigator/s:    Dr Paul Devenish-Meares

                                       Ph 61 7 3840 8336

Contact Person/s:            Dr Paul Devenish-Meare

                                      Ph 61 7 3840 8336

© IMPACT/PSANZ 2001