Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety...

Area of Science:

• Obstetrics and Gynecology
• Neonatal Health
• Vaccine Safety Research

Background:

• Preterm birth (before 37 weeks gestation) affects 15 million infants globally, disproportionately impacting low and middle-income countries (LMICs).
• It is a leading cause of neonatal mortality (1 million deaths annually) and significant childhood morbidity.
• Accurate gestational age assessment is crucial but challenging due to variable data availability (e.g., last menstrual period, ultrasound).

Framework:

• A novel case definition is proposed to categorize preterm births with varying levels of confidence.
• This framework utilizes diverse assessment modalities potentially available across different clinical settings.
• It aims to standardize preterm birth classification for robust safety evaluations.

Implementation:

• The case definition is designed for use in vaccine clinical trials and post-implementation immunisation programs.
• It accommodates settings with limited or varying data for gestational age determination.
• Facilitates systematic safety monitoring of maternal immunisation initiatives.

Implications:

• Enhances the reliability of preterm birth data in vaccine safety studies.
• Supports improved monitoring of vaccine efficacy and safety in pregnant populations.
• Aids in understanding the true burden and impact of preterm birth globally, particularly in LMICs.