EGA Institute for Women's Health


How were patients and public involved in developing MFAET?

A group of public and patient representatives advised on the work.

Gift-surg, Institute for Women's Health, UCL
This group was made up of participants from several UK charities with interests and expertise in the area of complicated pregnancies and births as well as representatives from academic and medical teams. The group looked at the findings from an early stage of the research work and provided feedback on them. They gave advice on the types of adverse events (AEs) which were included. And they advised on how to consider the seriousness of these events.


The group supported the approaches set out in the work for recording and assessing AEs in trials including pregnant women1. They suggested that the times at which AEs were recorded should be planned in advance for each trial. Members of the group also took part in the detailed Delphi consultation process alongside clinical and research specialists in the area. The Delphi process helped to decide how the seriousness of different types of events should be assessed.

The group raised some wider points that researchers should consider when planning and carrying out trials in pregnant women, especially when these trials were looking at treatments for babies in the womb. These were included in the paper published from work. Recommendations included providing support for women and their partners during trials  and an assessment of the impact of the treatment on both women and partners.  They highlighted the need to look at the pain or stress response of the unborn baby to some treatments. The group also suggested consideration of long-term outcomes of the pregnancy and birth, and consideration of future pregnancies.

1 We have followed the example of NICE in using the term pregnant women but this work should be understood to apply to people who are pregnant including those who do not identify as women. 

For details of the group which was consulted see GIFT-Surg Patient and Public Advisory Group.  


BLISS charity
Shine charity
CDH Charity
Twins Trust
Antenatal results and choices
Stillbirth and neonatal death charity