INSIGHT-2: mechanistic studies into pregnancy complications and their impact on maternal and child health—study protocol

Pregnancy and early childhood cohorts provide a framework for investigating the complex interplay between early-life exposures and health outcomes, thereby informing prevention strategies and interventions to improve maternal and child health. In this paper, we outline the objectives, methodologies and expected contributions of INSIGHT-2, a comprehensive cohort study dedicated to advancing our understanding of pregnancy and pregnancy complications towards improving the health and well-being of mothers and their offspring.

Over the course of 5 years, the study aims to establish a diverse cohort of 1700 pregnant women and to follow up their children up to 2 years of age. Recruitment targets participants with healthy pregnancies, preexisting conditions, and/or risk factors for pregnancy complications or later child health problems. Clinical and lifestyle data and a range of biological samples will be collected, providing a comprehensive resource for biomarker investigations and cross-sectional analyses. It is anticipated that the cohort will continue beyond this initial 5-year plan.

By gathering a wide range of biological samples and using diverse analytical techniques, this study supports broad participation, potential replication and collaboration across various sites. The extensive collection of longitudinal data and samples not only facilitates current investigations but also establishes a biobank for future research. The exploration of pre-pregnancy and pregnancy factors that may contribute to disease processes and impact fetal well-being and future health will provide a comprehensive picture of disease mechanisms in both mothers and children, facilitating the identification of biomarkers for the prediction, diagnosis, and management of pregnancy complications. Additionally, our diverse population allows for the capture of various pregnancy complications and outcomes, enhancing external validity and addressing health disparities. This comprehensive design ultimately aims to improve maternal and child health outcomes by providing a valuable longitudinal study of the relationships among the in utero environment, pregnancy management, and long-term maternal and child health, ensuring that findings are relevant and beneficial to a broader population.