Specific concerns CANA and Maternity Coalition have regarding the BAC trial are:

That consumer concerns raised in November 2002 have been ignored by the researchers and either not passed onto the collaborating hospitals’ HRECs or dismissed.

1. That consumer advocacy groups were apparently not consulted by the HRECs which approved the trial despite NHMRC recommendations to do so in relation to research on women (Human Research Ethics Handbook, 2001).

2. That the researchers presume to show what is best for women when care should be based on women’s individual needs.

3. That the study design is significantly flawed and the trial unethical given that:

Participant information sheets contain inaccurate and incomplete information on the risks and benefits of each mode of birth[1].

Healthy pregnant women with uncomplicated pregnancies are being actively encouraged to participate in the randomised controlled trial (RCT) arm of this study (there is also a patient-preference arm) despite the fact that they may be excellent candidates for VBAC.[2]

The majority of participants will be reluctant to leave their babies’ births to chance, so it is likely the RCT will not attract enough women to be considered scientifically valid.[3]

Women who are committed to achieving a birth outcome will be excluded from the RCT. ie, the only women who will participate in the RCT don’t care how they give birth. This means that the RCT does not take into consideration the influence of motivation and other psychological factors.[4]

The RCT arm of the trial puts an unfair burden of participation on vulnerable women who lack enough information and social support to make an informed decision based on their individual needs and wellbeing.[5]

There is inadequate research to assess psycho-social factors contributing to birth outcomes after caesarean or to assess the best models of care for vaginal birth after caesarean. Therefore some obvious gaps in the research that should be addressed prior to subjecting women to major surgery have not been thoroughly examined.[6]

Women in the VBAC groups may be put at greater risk of harm and disadvantage because of the imposition of unnecessary routine interventions during labour, fragmented care by birth attendants who may not necessarily support normal birth after a previous caesarean or clinicians who have high intervention and caesarean rates and low VBAC rates[7].

The only women who will agree to be randomly allocated to surgery or VBAC will have no strong preferences for how they birth, women in the VBAC group of the RCT may therefore lack motivation and information on how to optimise their chances for an uncomplicated vaginal birth.

Inconsistencies in administration of the trial are unavoidable in each VBAC group. The nature of the clinician:woman relationship dictates that women in the VBAC group will be influenced by the attitudes, opinions, preferences, practices and experience of attending obstetricians and midwives and these will vary greatly. [8]

A major multi-centre RCT which demonstrated many of these flaws (The Term Breech Trial) had a devastating impact on the way in which women birthed despite the fact that study design flaws and faulty analysis have seen a call for the original recommendations to be withdrawn. Despite this, the lasting impact of this research will continue to affect women and their families well into the future[9].