The PRotective Effect of Maternal Immunisation on preTerm birth: Underlying mechanisms and Role in newborn immune function (PREMITUR) Study.

Not Applicable

Recruiting

• Conditions: Pregnancy; Vaccination; Inflammatory and Immune System - Normal development and function of the immune system; Pre-term birth; Reproductive Health and Childbirth - Normal pregnancy

• Registration Number: ACTRN12623000170628
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-17
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

•Nulliparous women
•Aged 18 to equal to 45 years
•Available for the entire study period
•Gestation between 9 and 22 weeks at time of recruitment.
•Willing and able to comply with all study requirements including timing and/or nature of required assessments and follow up of mother and baby to six weeks post-partum

Exclusion Criteria

•Multiparous women
•Multiple pregnancy
•Unable to provide consent
•Concomitant immunosuppressive medication likely to continue beyond first trimester
•Any other significant acute or chronic medical condition that in the opinion of the investigator may interfere with the interpretation of study results or place the participant at increased risk if they participate in the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified