Kits and methods to distinguish false labor and true labor
Inventors
TARCA, Adi L. • Chaemsaithong, Piya • Chaiworapongsa, Tinnakorn • Hassan, Sonia S. • Romero, Roberto
Assignees
Wayne State University • US Department of Health and Human Services
Publication Number
US-12287340-B2
Publication Date
2025-04-29
Expiration Date
2036-11-07
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Abstract
Kits and methods to distinguish between false and true labor are provided. The kits and methods can utilize differences in abundance and/or differences in the rate of change in abundance of B7-H2, SORC2, TF, C1-Esterase Inhibitor, Ran, IMDH1 and/or PGAM1, as markers of true labor.
Core Innovation
The invention provides kits and methods to distinguish between false and true labor in pregnant females by measuring and analyzing a panel of maternal blood plasma biomarkers. Specifically, the disclosure identifies seven biomarkers, namely B7-H2, SORC2, TF, C1-Esterase Inhibitor, Ran, IMDH1, and PGAM1, whose abundance and/or rate of change in abundance can serve as indicators of true labor. The kits include arrays or immunoassay-based detection tools and instructions for collecting and analyzing these markers.
The invention addresses the longstanding clinical challenge of accurately diagnosing true labor, which is currently based on retrospective criteria such as symptoms and cervical examination, methods that often result in poor specificity and can lead to unnecessary hospitalizations, medical interventions, and increased risk of iatrogenic complications. Overdiagnosis of labor, especially preterm, significantly impacts healthcare costs and patient outcomes, as up to 40% of women presenting with preterm labor symptoms are misdiagnosed.
The core innovation involves two predictive models. In the first, the rate of change (slope) in protein abundance of B7-H2, SORC2, TF, and C1-Esterase Inhibitor across at least two measurements during pregnancy is used to distinguish true labor. In the second, the absolute change in abundance of TF, Ran, IMDH1, and PGAM1 at the time of patient admission relative to reference levels is assessed. These models, individually or in combination, allow calculation of a true labor score, facilitating objective determination of labor status and reducing reliance on conventional, less specific diagnostic methods.
Claims Coverage
There is one independent claim which details the main inventive features of the kit.
Kit with array to measure TF, Ran, IMDH1, and PGAM1 in pregnant female samples
The inventive feature consists of a kit that comprises: - An array that measures tissue factor (TF) in combination with Ras-related Nuclear protein (Ran), Inosine-5′-monophosphate dehydrogenase (IMDH1), and Phosphoglycerate mutase 1 (PGAM1). - The measurements are performed from a sample obtained from a pregnant female.
The inventive features are focused on a kit that provides an array capable of analyzing the specific marker combination of TF, Ran, IMDH1, and PGAM1 from pregnant female samples in order to facilitate the distinction between true and false labor.
Stated Advantages
The kits and methods can achieve specificity as high as 94%, reducing unnecessary hospital admissions, medical interventions, and costs by accurately identifying true labor.
A negative test result indicates that patients are highly unlikely to deliver, allowing avoidance of interventions such as analgesia and labor induction or augmentation.
The approach enables objective and robust diagnosis of true versus false labor, overcoming the limitations of clinical symptoms and cervical examination, which lack adequate predictive value.
Documented Applications
Identifying true labor versus false labor in pregnant females, especially when the patient presents with symptoms associated with labor, such as contractions.
Guiding clinical decisions regarding hospital admission and medical intervention for pregnant women experiencing symptoms of labor by providing an objective test result.
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