External Validation Study of First Trimester Obstetric Prediction Models (Expect Study I): Research Protocol and...

Area of Science:

• Obstetrics and Gynecology
• Clinical Prediction Modeling
• Epidemiology

Background:

• Numerous first-trimester prediction models for obstetric outcomes exist but lack external validation.
• External validation is critical for clinical implementation of prediction models.
• The Expect Study I aims to address this gap in the Dutch obstetric population.

Purpose of the Study:

• To externally validate existing first-trimester prediction models for pre-eclampsia, gestational diabetes mellitus, spontaneous preterm birth, small-for-gestational-age, and large-for-gestational-age infants.
• To assess the feasibility and acceptability of the recruitment process and questionnaire comprehensibility through a pilot study.
• To evaluate the generalizability of these models in a Dutch cohort.

Main Methods:

• A multicenter prospective cohort study (Expect Study I) conducted in The Netherlands (2013-2015).
• Systematic literature review to select first-trimester prediction models.
• Data collection via Pregnancy Questionnaire 1 and Postpartum Questionnaire 1, supplemented by medical records.

Main Results:

• Pilot study led to minor improvements in recruitment and the Pregnancy Questionnaire 1.
• The validation cohort comprises 2614 women.
• Data analysis for external validation is currently in progress.

Conclusions:

• The study will provide insights into the generalizability of non-invasive first-trimester prediction models for various obstetric outcomes in the Netherlands.
• Results will inform the selection of best-performing models for the Dutch setting.
• A subsequent impact study (Expect Study II) is planned to evaluate clinical outcomes, costs, and quality of life.