A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor

Study Overview
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Brief Summary
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Prospective multicenter observational study to further develop and validate a preterm birth risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks gestation. A single maternal peripheral blood sample will be collected for analysis. Data related to potential risk factors for preterm birth will be obtained through maternal interview and review of medical records. Subjects will be followed through the delivery process to assess the course of pregnancy, labor, and to document any related maternal complications. Neonatal outcomes will be gathered from the medical record for up to 28 days of life or discharge, whichever occurs first.

Official Title
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A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor

Conditions
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Preterm Birth

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years of age or older Subject has singleton gestation Subject is able to provide consent Gestational age is confirmed by a documented crown rump length on an ultrasound performed at the study site within 6 0/7 weeks and 13 6/7 weeks gestation (first trimester) Subject has no signs and/or symptoms of preterm labor and has intact membranes Investigator believes subject is willing to comply with study visits and procedures Investigator believes the subject's delivery data will be available within 15 business days from delivery, and neonatal data will be available for data collection purposes within 15 business days from discharge Exclusion Criteria: The subject has a planned cesarean section or induction of labor prior to 370/7 weeks of gestation The subject has a planned cerclage placement for the current pregnancy There is a known or suspected fetal anomaly or chromosomal abnormality The subject has had a blood transfusion during the current pregnancy The subject has known elevated bilirubin levels (hyperbilirubinemia) The subject has taken or plans to take any of the following medications during the current pregnancy: Progesterone or progesterone-derivative medication after 13 6/7 weeks gestation Enoxaparin, heparin, heparin sodium, low molecular weight heparin after first day of last menstrual period The subject has participated in, or plans to participate in, an interventional treatment study during the current pregnancy The current pregnancy was previously a multiple gestation that is now a single fetus due to reduction, vanishing twin, etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with preterm delivery<br> | |
| Women without preterm delivery<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the receiver operator characteristic curve (AUROC) for prediction of preterm versus term birth using freshly collected specimens. |  | Up to 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proteomics, pregnancy, biomarkers, preterm birth