PERINATAL TRIALS REPORT

PT0520

Women and the Induction of Labour Dilemma-Trial B

Plain Language Summary:      Whilst some women actively seek out induction, others oppose nedical interventions to end their pregnancy. Breast and nipple stimulation may be one alternative that women could consider when induction is indicated. It is a traditional practice used across many cultures to induce and augment labour. Additionally, it is inexpensive and offers women control over their induction.

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 nipple stimulation will lead to a lower CS rate when compared with ARM alone, to somewhere between the 30.5% associated with ARM and the 12.3% associated with spontaneous labour. AN arbitrary midpoint of 21% was therefore chosen, as a smaller difference would not be clinically meaningful. Power and sample size calculations were thererefore based on an expected difference of 30% and 21%.

Type of administration:       Single centre

Prinicipal Investigator/s:     Ms Jocelyn Toohill

                                        Ph 61 7 3840 8029

Contact Person/s:             Ms Jocelyn Toohill

                                       Ph 61 7 3840 8029

© IMPACT/PSANZ 2001