ArticlePregnancy (Hoboken, N.J.)2026
Neonatal impact of maternal biomarker screening for risk of preterm birth with targeted interventions (PRIME): A multicenter, randomized, controlled trial.
Article in Pregnancy (Hoboken, N.J.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04301518 (Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
Who cites it
2 citing papers in PubMed.
- Integrating Clinical Factors and Parity-Specific Models with Molecular Biomarkers to Better Predict the Risk of Preterm Birth in Asymptomatic Women.Diagnostics (Basel, Switzerland) · 2026Article
- Progress in reducing the burden of preterm birth: Are we ready for PRIME time?Pregnancy (Hoboken, N.J.) · 2026Article
Corrections and comments
- Erratum issued
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Preterm birth remains a leading cause of neonatal morbidity and mortality, yet clinicians possess limited tools to identify at-risk pregnancies and implement effective interventions. This study evaluated whether knowledge of a mid-second-trimester maternal blood biomarker test result, combined with an intervention bundle for those identified as being at higher risk, improves neonatal outcomes in a population at low overall risk for spontaneous preterm birth. Methods: PRIME was a multicenter, randomized, controlled trial at 19 US sites. Participants with singleton pregnancies at 18-20 Results: The enrolled population included 5018 participants with delivery data available for 4806, comprising the intent-to-treat population (2416 screen-guided care, 2390 routine care). Screen-guided care was associated with reduced composite neonatal morbidity (odds ratio [OR], 0.80; 95% confidence interval [CI], 0.66-0.96; Conclusion: In low-risk pregnancies, care guided by a maternal IGFBP4/SHBG blood test with targeted interventions improved neonatal outcomes. These findings suggest a potential role for IGFBP4/SHBG screen-guided care in enhancing early risk detection and informing strategies to reduce events related to preterm birth. Trial Registration: ClinicalTrials.gov identifier: NCT04301518.
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Registered trials
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