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Better Estimation of Spontaneous Preterm Birth Prediction Performance through Improved Gestational Age Dating
Julja Burchard1, George R Saade2, Kim A Boggess3
1Sera Prognostics, Incorporated, Salt Lake City, UT 84109, USA.
Journal of Clinical Medicine
|May 28, 2022
Summary
Gestational age dating uncertainty impacts spontaneous preterm birth prediction. Excluding last menstrual period dating improved biomarker sensitivity, enhancing prediction accuracy for preterm birth risk.
Area of Science:
- Biomarkers and diagnostics
- Maternal-fetal medicine
- Proteomics and clinical prediction
Background:
- Accurate gestational age (GA) estimation is crucial for managing pregnancy and predicting spontaneous preterm birth (sPTB).
- Uncertainty in GA dating can affect the observed performance of predictive models.
- Proteomic biomarkers show promise for predicting sPTB risk.
Purpose of the Study:
- To evaluate how GA dating uncertainty influences the performance of a validated proteomic biomarker risk predictor for sPTB.
- To assess the generalizability of this effect across a wider range of GA at blood draw.
- To compare the performance of the risk predictor using different GA dating methods.
Main Methods:
- Secondary analysis of a prospective clinical trial (PAPR; NCT01371019).
- Comparison of two GA dating categories: ultrasound and last menstrual period (LMP) combined, versus excluding LMP dating.
- Performance evaluation of a validated proteomic biomarker risk predictor at a specific threshold, within standard (weeks 191/7-206/7) and extended (weeks 180/7-206/7) GA windows.
- Strict blinding and independent statistical analyses were maintained.
Main Results:
- The proteomic biomarker risk predictor demonstrated higher observed sensitivity (88% at 75% specificity) in subjects with more reliable GA dating (excluding LMP) compared to all subjects.
- Excluding LMP dating significantly improved sensitivity within the 191/7-206/7 GA window.
- In the broader GA window, the risk predictor effectively stratified sPTB risk, with improved sensitivity observed when LMP dating was excluded.
Conclusions:
- Gestational age dating uncertainty, particularly when including LMP dating, can attenuate the observed performance of sPTB risk prediction models.
- Excluding LMP dating improves the sensitivity of validated proteomic biomarker risk predictors.
- These findings are critical for accurately testing and validating models designed for predicting spontaneous preterm birth.
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