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.

Methods

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.

Discussion

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.


INSIGHT-2 seeks to recruit diverse pregnancy profiles, including the following:

  1. a.

    Participants with healthy pregnancies.

  2. b.

    Participants with risk factors for pregnancy complications, including GDM and sPTB.

  3. c.

    Participants with preexisting conditions such as systemic lupus erythematosus (SLE) and T1DM or with first-degree relatives/partners with these conditions.

Study size and population

Our target cohort size is 1700 participants. Recruitment began in November 2023 and is expected to continue for five years, with our recruitment centres being general and disease-specific antenatal clinics, specialist clinics for PTB, and maternal medicine surveillance. Demographics based on our previous INSIGHT study and our 230 participants enrolled up to July 2024 show that recruitment reflects the local population of the Lambeth area in terms of ethnicity (Table 1).


The maternal biological samples collected include cervicovaginal fluid, blood, and hair. Cord blood and placental samples are collected at birth, and child blood samples are collected at intervals ranging from 1 to 24 months of age. Saliva collection is possible in a future substudy. A description of the biological samples and the collection and storage details can be found under Additional file 1.

The data collected includes routine clinical information, mental health questionnaires, lifestyle information (sleep, exercise, and diet) (Table 3), fetal magnetic resonance imaging (MRI), and data linkages of participants and their children through the eLIXIR, Born in South London programme [35] (REC No: 23/SC/0116). The eLIXIR data-linkage project collects routine maternity and neonatal clinical patient data (uses opt-out consent at two NHS Foundation Trusts, GSTT and King's College Hospital NHS Foundation Trust (KCH)), mental health data, and primary care data.


Patient and public involvement and engagement (PPIE)

PPIE input was sought during the planning phases of the study. Surveys were distributed to gather insights on the acceptability of specific sample collection methods. A steering group has been established that includes PPIE members to oversee and monitor the progress of the study, contribute to identifying new research questions, review requests for sub-studies, and ensure ongoing collaboration and alignment with the needs and perspectives of the community.

Study sites

The main recruitment site is GSTT, with a planned expansion for the PISA sub-study to KCH. Other sites will be funding dependent.

Participant identification and eligibility criteria

Potential participants are identified through medical records, recruitment material (such as flyers and posters) displayed in antenatal settings, social media advertising, or face‒to-face encounters during antenatal visits.

Potential pregnant participants are eligible if they are booked at our hospital sites and are ≥ 16 years old and ineligible if they are unable to consent or have a known significant congenital, structural, or chromosomal fetal abnormality.

Consent and confidentiality

Participants provide written informed consent. Data and samples are link-anonymised in accordance with the UK Data Protection Act 2018 and the EU GDPR. For compliance with data protection legislation, the NHS Confidentiality Code, and the National Data Opt-Out Policy, potential participants are screened against national data opt-out. Participants can optionally consent to link study data to future health, education and social care outcomes via their NHS number, which includes Hospital Episode statistics, the Office for National Statistics and other related health/education and social care databases obtained through collaboration with the eLIXIR programme (REC No: 23/SC/01116).


Website: cognitivescientist.org 





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