An observational study in Preterm Birth, sponsored by HBI Solutions Inc.. Completed at 5 sites in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by HBI Solutions Inc. · Observational
Accurate prediction of preterm birth is critical for clinical management to improve the neonatal and maternal outcomes. A clinical challenge remains for current predicting biomarkers due to the complexity and multifactorial nature of underlying causes of preterm birth.
This study aims to evaluate the prediction performance of new maternal blood biomarkers (proteomic markers) on the occurrence of preterm birth.
Preterm birth (PTB), defined by delivery before 37 weeks of gestational age, represents a substantial public health challenge due to its elevated rates of neonatal morbidity and mortality worldwide. The prevalence of PTB exhibits variation, ranging from approximately 12-13% in the USA to 5-9% in other developed nations, underscoring a complex issue marked by regional disparities.
Emphasizing its significant public health ramifications, PTB is recognized as a primary contributor to mortality among children under five, particularly with 40% of deaths occurring within the first month of life in this demographic. Following PTB, infants face an increased vulnerability to severe complications like respiratory distress syndrome, intraventricular hemorrhage, and necrotizing enterocolitis, accentuating the acute threats to infant well-being and longevity. Addressing these early-life hurdles requires the formulation of robust strategies for prediction and prevention to alleviate the immediate hazards linked with premature birth.
Preventing PTB crucially depends on accurately identifying women at high risk. Interventions like vaginal progesterone and cervical cerclage are recommended for those with a short cervical length. However, the effectiveness of these strategies is frequently compromised by limitations in current screening methods, which struggle to accurately predict PTB. This underscores a significant gap in effectively identifying all at-risk women, underscoring the necessity for enhanced screening techniques to more precisely pinpoint women who would benefit from preventive interventions.
Current screening methods, primarily based on measuring cervical length and assessing historical risk factors, are inadequate in capturing the multifaceted nature of PTB risk, leading to missed opportunities for intervention and prevention. This inadequacy underscores the importance of developing methods that can more accurately identify women at high risk. Research efforts aimed at addressing these challenges suggest the potential of integrating new biomarkers and maternal characteristics into screening protocols to improve the predictive accuracy of PTB screenings.
Building upon the premise that the placenta plays a pivotal role in fetal health regulation, and that insights into the pathologic mechanisms leading to spontaneous preterm birth can be gleaned from the placental transcriptome, the investigators utilized existing transcriptomic data from the public domain, employing bioinformatics methodologies. This data was further complemented by quantitative proteomics analysis techniques using mass spectrometry. Through this integrated approach, the investigators have developed a novel PTB screening panel comprising three protein biomarkers. The efficacy and prediction performance of this three-protein predictor will be evaluated in this study with independent cohorts.
2,615 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 18,000 is above the median of 115 across 798 observational studies indexed under Premature Birth.
Browse Premature Birth studies →HBI Solutions Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
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General women with pregnancy
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Exclusion Criteria:
Pregnancy with delivery before 37 weeks of gestational age
Pregnancy with delivery at 37 weeks or later of gestational age
Prediction of preterm birth
The primary outcome is the prediction of preterm birth, defined as pregnancy duration of less than 37 weeks. Preterm birth prediction score is calculated as sum of the z-score of 3 proteins' multiple of median (MoM) values.
Time frame: After blood draw during doctor's visit before 37 weeks of gestation
Sensitivity, Specificity, Positive predictive value (PPV), Negative predictive value (NPV)
Sensitivity, Specificity, PPV and NPV was calculate for identification the preterm birth cases using pre-defined threshold of prediction score.
Time frame: After blood draw during doctor's visit before 37 weeks of gestation
Plan to share: No
Ran from Jan 2021 to primary completion in Jun 2023, 29 months.
Of 377 observational studies under Premature Birth, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 61. This study's 29 months is close to that.
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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HBI Solutions Inc.