Terms of reference for each of these committees will guide frequency of reviews despite and the conditions under which either committee would

advise the research team that enrolment to the trial should cease. Discussion This will be the first study to provide rigorous evidence regarding the practice of antenatal expression of colostrum in late pregnancy for women with diabetes in pregnancy. It will explore the safety and efficacy for mother, fetus and infant. There remains widespread national and international interest in the outcomes of this trial, and the controversy can be seen in a recent review which concluded antenatal expressing should be encouraged: “Although Forster et al43 have argued the

teaching of [antenatal expressing] should cease until the practice is proven to be safe and effective…an ethical dilemma now exists…as to whether the benefits of early colostrum feedings in at-risk babies outweighs the unproven side effect of premature labour.52 In the absence of evidence, the clear benefits of early feedings of colostrum should outweigh the unsupported risks of ceasing [antenatal expressing] education.”53 Trial status Approval has been granted from the following Human Research Ethics Committees (reference number in brackets): RWH (11/07); MHW (11/06); La Trobe University (11-004); Monash Medical Centre (12181-B); Barwon Health (13/06); Peninsula Health (14/PH/21). Recruitment started at RWH in June 2011, followed by MHW in July 2011. In May 2012, due to (A) the slow recruitment rate resulting

from low numbers of eligible women, and (B) external expert advice to include women with diabetes in pregnancy who did not require insulin, thereby increasing the trial’s external validity, it was agreed to amend our inclusion criteria to include all women with diabetes in pregnancy (not just those requiring insulin) and to identify and recruit further trial sites. Monash Medical Centre started in October 2012 and Barwon Health (Geelong Hospital) in April 2013. The last site, Frankston Hospital, had ethics approval from Peninsula Health in July 2014 Anacetrapib and recruitment will start soon. In the original protocol women who had a history of spontaneous preterm birth or who had threatened preterm birth in the current pregnancy were excluded, however following the Safety Committee review of the first 100 births, which found no evidence of contractions following expressing, and because no woman is randomised prior to 36 weeks gestation, this exclusion criterion was removed.