A Questionnaire-based Study Exploring Participant Perspectives in a Perinatal Human Challenge Trial.

ABSTRACT:

Background

Pregnant women have historically been excluded from most medical research, including human challenge studies. The proof-of-concept Lactamica 9 human challenge study investigated whether nasal inoculation of pregnant women with commensal bacteria leads to horizontal transmission to the neonate. Given the unique practical and ethical considerations of both human challenge studies and interventional research involving pregnant women and their newborns, we sought to investigate the motivations, concerns and experiences of these volunteers.

Methods

Pre- and post-participation questionnaires were given to all participants in the Lactamica 9 study. These fully anonymized qualitative and Semi-quantitative questionnaires used forced Likert scales, word association and free

SUBMITTER: Bevan JHJ 

PROVIDER: S-EPMC10569679 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature