Biomarker‑guided screening in first‑time pregnancies has been linked to fewer NICU admissions, according to a secondary analysis of the PRIME trial published in a peer‑reviewed obstetrics journal.
Study design and biomarker details
The PRIME randomized controlled trial enrolled 5,018 low‑risk singleton pregnancies across 19 centers. Researchers focused on the IGFBP4/SHBG ratio, a blood test taken in the mid‑second trimester that measures insulin‑like growth factor‑binding protein 4 against sex hormone‑binding globulin. Prior multicenter research reported the test’s sensitivity at 75 % and specificity at 74 % for spontaneous preterm birth, with an area under the ROC curve of 0.75.
In the trial, participants were assigned either to a screen‑guided care arm or to routine care. Those who screened as higher risk received a bundled intervention: vaginal progesterone, low‑dose aspirin, and weekly telephonic nursing support. All other participants continued with standard prenatal management. The analysis considered only the 1,783 nulliparous (first‑time) pregnancies.
Key outcomes for nulliparous women
Compared with routine care, the screen‑guided group showed a lower rate of NICU admission—12.8 % versus 16.4 % (P = .039). Adjusted models, which accounted for pre‑enrollment aspirin use and COVID‑19 status, produced an odds ratio of 0.75 (95 % CI 0.57‑0.98; P = .036). The number needed to screen was 28 nulliparous pregnancies to prevent one NICU admission.
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Reductions in NICU admissions were most evident among spontaneous preterm births. No serious adverse events were reported among participants receiving the bundled regimen, indicating the intervention’s tolerability.
These findings come amid ongoing concerns about preterm birth, which remains the leading cause of neonatal mortality and contributes substantially to long‑term childhood morbidity. Conditions such as respiratory distress syndrome, bronchopulmonary dysplasia, sepsis, and intraventricular hemorrhage are commonly associated with premature infants, especially those requiring intensive care.
Nulliparous pregnancies consistently carry a higher risk of preterm delivery than those following a prior full‑term birth, yet conventional risk assessment tools—clinical history and cervical length—explain fewer than one‑third of preterm births. The study suggests that adding a biomarker‑based approach may fill that gap.
From a broader perspective, this result mirrors earlier efforts to integrate laboratory markers into obstetric care, such as the use of fetal fibronectin for predicting imminent preterm labor. While those tests have had mixed success, the present analysis indicates that a well‑validated biomarker panel can translate into measurable clinical benefits when paired with targeted prophylaxis.
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Implications and next steps
Authors of the analysis note that the bundled intervention was well‑tolerated, and they emphasize the potential of biomarker‑guided strategies to improve outcomes for first‑time mothers without prior obstetric history. Adjustments for aspirin use before enrollment and for COVID‑19 status aim to isolate the effect of the screening protocol itself.
Future research may explore whether similar screening could be extended to broader obstetric populations or integrated with other preventive measures. The current evidence, however, supports the utility of the IGFBP4/SHBG ratio as a tool for identifying women at raised risk of spontaneous preterm birth and for guiding interventions that reduce NICU utilization.
Screening saves lives.
