SEARCHRCTobstetrics and gynecology, pediatrics

RCT·obstetrics and gynecology, pediatrics, clinical trial, epidemiology·PMC10487576

Prediction and Prevention of Preterm Birth: Secondary Analysis of a Randomized Intervention Trial

Journal of Clinical Medicine · 4 authors, 4 centres

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TL;DR

In a secondary analysis of the PREVENT-PTB RCT, screening with the PreTRM proteomic test was associated with significant prolongation of pregnancy (adjusted hazard ratio 0.53) among the earliest decile of births compared to no screening.

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Key limitations include the post hoc nature of the analysis, small number of preterm birth cases due to early trial termination, absence of antenatal corticosteroid data, and non-randomized treatment choices based on patient preference.

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RCT

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obstetrics and gynecology

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ORIGINAL PAPER

PMC10487576

Prediction and Prevention of Preterm Birth: Secondary Analysis of a Randomized Intervention Trial

Journal of Clinical Medicine

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ABSTRACT

Abstract Our objective was to evaluate whether pregnancy is prolonged by the use of a proteomics-based maternal serum screening test followed by treatment interventions. This is a secondary analysis of the PREVENT-PTB randomized trial comparing screening with the PreTRM test versus no screening. The primary trial analysis found no significant between-group difference in the preterm birth rate. Rather than considering a dichotomous outcome (preterm versus term), we treated gestational age at birth as a continuous variable using survival analysis. We also evaluated between-group difference in NICU length of stay and duration of respiratory support. Results indicated that pregnancy was significantly prolonged in subjects screened with the PreTRM test compared to controls (adjusted hazard ratio 0.53, 95% confidence interval 0.36–0.78, p < 0.01). Newborns of screened subjects had significantly shorter NICU stays but no significant decrease in duration of respiratory support. In the PreTRM screen-positive group, interventions that were associated with pregnancy prolongation included care management and low-dose aspirin but not 17-hydroxyprogesterone caproate. We conclude that screening with the PreTRM test followed by interventions for screen-positive pregnancies may prolong pregnancy and reduce NICU LOS, but these observations need to be confirmed by additional research. Keywords: 17-hydroxyprogesterone caproate, care management, length of stay, low-dose aspirin, neonatal respiratory morbidity, preterm birth, proteomic biomarkers, risk assessment

CITATION EXPORT

C Andrew Combs, John A F Zupancic, Michael Walker et al.. Prediction and Prevention of Preterm Birth: Secondary Analysis of a Randomized Intervention Trial. Journal of Clinical Medicine. (2023). https://doi.org/10.3390/jcm12175459

AUTHORS

4 · 4 CENTRES

C Andrew Combs, John A F Zupancic, Michael Walker, Jing Shi

1Pediatrix Center for Research, Education, Quality & Safety, Sunrise, FL 33323, USA
2Department of Neonatology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA
3Department of Pediatrics, Harvard Medical School, Boston, MA 02115, USA
4Statistics Consultant, Carlsbad, CA 92009, USA