Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study.

ABSTRACT:

Objective

Trial legislation enables research to be conducted without prior consent (RWPC) in emergency situations, yet this approach has rarely been used in time-critical obstetric trials. This study explored views and experiences of antenatal recruitment and consent and RWPC in an emergency intrapartum randomised clinical trial.

Design

Embedded, mixed-methods study within a trial, involving questionnaires, recorded recruitment discussions, interviews and focus groups in the first 13 months of trial recruitment (December 2020-January 2022).

Setting

COPE is a double-blind randomised controlled trial, comparing the effectiveness of carboprost or oxytocin as first-line treatment of postpartum haemorrhage.

Participants

Two hundred and eighty-six people (190 women/9

SUBMITTER: Deja E 

PROVIDER: S-EPMC10862288 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature