Background

CARES-SA (a South Australian support group for women who have had caesareans) was initially consulted about the BAC trial (previously titled ACTOBAC) in September 2002.

CARES-SA provided feedback detailing significant ethical concerns and problems with the wording of the participant information sheets to the Principal Investigator Caroline Crowther on November 4, 2002.

CARES-SA received a generic response from Prof. Crowther stating that the trial had already received preliminary approval to proceed on December 4, 2002.

CARES-SA responded to this letter asking for further clarification on how their recommendations were taken on board on January 16, 2003.

CARES-SA received no response from the Principal Investigator to that enquiry nor any subsequent enquiries.

The Trial was approved by the Women’s and Children’s Hospital (WCH), Adelaide, Human Research Ethics Committee (HREC) and the University of Adelaide, South Australia. It has subsequently received approval based on the recommendations by the original HREC by at least 10 other collaborating hospitals. The Mater Mother’s Hospital HREC approved the trial in January 2005. The NHMRC is funding the trial.

Birthrites and the Maternity Coalition wrote to the WCH HREC regarding the ethical concerns with the trial and the WCH HREC responded on June 4th that they failed to see why Birthrites thought the information was biased towards caesareans and that they felt it was ethical.

The study design was altered after the preliminary trial possibly because of a lack of willing participants in the RCT. The study is now both an RCT and a patient-preference study.

At least 13 Hospitals are currently recruiting women for the trial in four Australian States.

1000 women have agreed to participate thus far and 12 of those have agreed to be randomly allocated to either major surgery or VBAC.

Despite the fact concerns were raised regarding the trial prior to HREC approval, the CEO at the Mater Mothers’, Brisbane has stated that “no concerns were raised” with the HREC that originally approved the trial.

Despite CARES-SA objections to the information leaflet, it has not been altered for the current trial, with the minor exception of a line added to state that women’s chances of VBAC may be reduced after a caesarean.

To date, the hospitals and the researchers state they have received no complaints from participants. However, Maternity Coalition and other birth support groups have received complaints from participants in Townsville, Brisbane and Adelaide.

Maternity Coalition (Qld) wrote to the CEO of the Mater Mothers’ Hospital, the HREC secretary for the same hospital and CC’d the letter to several organisations including the Queensland Government Minister for Health. The CEO and the Minister both advised Maternity Coalition to raise concerns with the Principal Investigator.

Maternity Coalition wrote to the Principal Investigator in March this year and has received no response.

Maternity Coalition has written to the HREC at the University of Adelaide to ascertain if CARES-SA concerns were passed on to the approving HREC and if they were, why they were dismissed and consumers not kept updated with the progress of the trial.

Maternity Coalition was informed by the university that the HREC that initially approved the trial was based at the Children, Youth and Women’s Health Service in Adelaide (CYWHS, formerly WCH).

MC wrote to the research ethics committee at the CYWHS on May 17 and received a reply on July 17 stating that the committee still supported the study. None of the questions put to the committee were addressed. This includes their knowledge of consumer concerns, complaints by participants and midwives and problems related to inaccuracies and inadequate information on the trial information sheets.

Furthermore, the CYWHS committee commented that people involved in clinical care were not involved with trial recruitment. This has been refuted by a midwife at a participating hospital who has reported to MC that midwives involved in the care of these women are recruiting for the trial.

On August 8th, 2006 Maternity Coalition sent a letter and detailed brief regarding concerns raised about the research to the Federal Minister for Health Tony Abbott.