Family and health professional perspectives on the use of two-stage consent in pregnancy research.
Objective
To explore the experiences of women approached for enrolment into the PROMOAT trial using a staged consent pathway (consent for trial intervention and short-term data collection), followed by consent to continue when full immediate prospective consent is not practicable.
Who will be eligible?
Participants and site teams who have used these modes of consent for the PLATIPUS PROMOAT study will be surveyed by Dr Amir Zayegh.
Why are we doing this study?
Within PROMOAT, we are testing two (slightly) different ways of inviting women to take part.
Why is this important?
We want to know if breaking up the information into two sessions is as satisfactory and effective as full immediate provision of information, when we are studying which urgent treatments are safest and most effective in pregnancy or labour.
Funder: N/A
Ethics Reference: HREC/111728/RCHM-2025
Trial Registration: Sub-study of NCT06906757
Dr Amir Zayegh
Principal Investigator, Neonatologist
Assoc. Prof. Clare Whitehead
Maternal and Fetal Medicine Specialist
Prof Brett Manley
Professor, Neonatology
Dr Trisha Prentice
Ethics Advisor
Platform for Adaptive Trials in Perinatal Units
