The National Blood Authority (NBA) released the Guidelines on the Prophylactic Use of Rh D Immunoglobulin (Anti-D) in Obstetrics in 2003, with the aim of providing clinical guidance on antenatal prophylaxis. These guidelines also addressed supply constraints at the time of publication by including a staged implementation process for a full antenatal prophylaxis program in Australia.
In December 2014 there was an update of the Rh(D) Immunoglobulin-VF Product Information by CSL Behring regarding patients with a Body Mass Index (BMI) ≥30. As BMI was not addressed in the 2003 Guidelines, an expert panel was convened by the (then) Australian Red Cross Blood Service and the NBA to develop an Expert Panel Consensus Position Statement regarding the use of Rh(D) immunoglobulin in patients with a Body Mass Index ≥30.
In October 2016, the NBA and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) agreed to update clinical guidance relating to antenatal prophylaxis in women who are Rh D negative, in accordance with current evidence and consensus among clinical experts.
A multidisciplinary Expert Reference Group (ERG) with expertise from a range of clinical settings was established to identify the key issues that should be investigated for a new evidence-based Guideline for the prophylactic use of Rh D immunoglobulin in pregnancy care and to oversee the development of the Guideline. The following key areas of concern were identified and investigated:
- Does the available evidence still support universal routine antenatal prophylaxis?
- Should universal routine antenatal prophylaxis be moved from a two-dose regimen to a one-dose regimen?
- Should the list of sensitising events in the first 12 weeks of pregnancy be amended to include additional events?
- To reduce unnecessary use of Rh D immunoglobulin, should non-invasive prenatal screening be used in the first trimester so that prophylaxis can be targeted?*
- Does increasing BMI impact on the efficacy of Rh D immunoglobulin?
The draft guideline was open for public consultation from 20 September 2019 to 8 November 2019. Seventeen submissions were received, comprising 166 comments. The ERG has reviewed all comments related to clinical guidance. Comments relating to access and implementation are being reviewed by the NBA before they are referred to governments for further consideration. The draft guideline will subsequently undergo an AGREE II assessment to confirm the methodological rigour and transparency in which it was developed.
The volume of feedback received during public consultation exceeded expectations and has extended the timeframe for finalising the guideline.
It is anticipated that the final Guideline for the prophylactic use of Rh D immunoglobulin in pregnancy care will be released later in 2020.
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