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

Area of Science:

• Obstetrics and Gynecology
• Infectious Disease Research
• Maternal-Fetal Medicine

Background:

• Historically, pregnant women have been excluded from medical research, including human challenge studies.
• The Lactamica 9 study explored nasal inoculation of pregnant women with commensal bacteria to assess neonatal transmission.
• Ethical and practical considerations for research involving pregnant women and newborns are significant.

Purpose of the Study:

• To investigate the motivations, concerns, and experiences of pregnant volunteers in a human challenge study.
• To assess the feasibility and acceptability of human challenge research in pregnant populations.
• To understand participant perceptions of study interventions and procedures.

Main Methods:

• Utilized fully anonymized, qualitative, and semi-quantitative questionnaires (pre- and post-participation).
• Employed forced Likert scales, word association, and free-text questions to gather data.
• Achieved high response rates for pre-participation (87.1%) and post-participation (62.5%) questionnaires.

Main Results:

• Most participants were motivated by altruism and perceived the intervention as "natural," "protective," and "safe."
• Concerns primarily related to procedural discomfort, with minimal concern for self or infant risk (18.5% and 22.2%, respectively).
• Post-participation, 93.3% found procedures acceptable, with positive feedback on research team interactions.

Conclusions:

• Human challenge research in healthy pregnant women is demonstrated to be acceptable and feasible.
• Altruistic motivations and the perception of the intervention as "natural" were key factors.
• The Lactamica 9 study provides a successful model for future research involving pregnant populations.