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NCT01148654 · ClinicalTrials.gov registry record

The Biomarker Study

A clinical trial, sponsored by University of Pennsylvania.

Completed
Registry status
1,076
Enrollment target

NCT01148654: Completed study, sponsored by University of Pennsylvania.

NCT01148654 is a clinical trial that has completed, run by University of Pennsylvania. The registered enrollment target is 1,076 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01148654 has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
1,076 participants
Enrollment target

Study Summary

Preterm birth (PTB) is a leading contributor to perinatal morbidity and mortality. While patients with preterm labor (PTL) are at an increased risk for PTB, not all PTL patients will deliver preterm. In patients with PTB, there is a high prevalence of 'intrauterine inflammation' as demonstrated by a large body of evidence. The presence of inflammation is noted by infiltration of inflammatory cells in the placenta and/or maternal fever in labor and/or elevation of cytokines in the amniotic fluid. Despite this significant association of inflammation with PTB, identification of women destined to deliver preterm by inflammatory markers in maternal blood has not been successful. To date, it has been difficult to determine which patients with PTL will experience PTB. Identification of biomarkers, such as high sensitivity C-Reactive Protein (hsCRP) as well as others such as sICAM, Pentraxin, sE-Selectin, and CxCL-10 in maternal serum and in placental cord blood, may help to serve three very important clinical aims. 1) Identification of novel biomarkers in maternal serum could help to distinguish those women with PTL who are most likely to deliver PTB. 2) These biomarkers may have a high negative predictive value and thus identify those women who are not likely to deliver preterm, avoiding undue hospital admission and medical therapies. 3) Select biomarkers in the mother and/or in cord blood may serve to identify those preterm neonates at greatest risk for adverse outcome. Through improved identification of these infants, studies with targeted therapies to reduce adverse neonatal outcomes in preterm neonates become feasible. This study involves a cohort assessment of women at risk for Preterm birth secondary to preterm labor, preterm premature rupture of membranes (PPROM), and cervical insufficiency (CI), between 22-0/7 and 33-6/7 weeks gestational age. We will obtain information regarding patients' pertinent past medical and obstetric history as well as small samples of

Trial Details

FieldValue
Enrollment Target 1,076 participants
Start Date 2008-05
Est. Completion 2012-06

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT01148654

The ClinicalTrials.gov registry entry for NCT01148654 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,076 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01148654 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01148654 about?

NCT01148654 is a clinical study titled "The Biomarker Study". Preterm birth (PTB) is a leading contributor to perinatal morbidity and mortality. While patients with preterm labor (PTL) are at an increased risk for PTB, not all PTL patients will deliver preterm. In patients with PTB, there is a high prevalence of 'intrauterine inflammation' as demonstrated by a...

What is the current status of trial NCT01148654?

This trial is currently completed. The enrollment target is 1,076 participants. The study started on 2008-05. Estimated completion is 2012-06.

Who is sponsoring clinical trial NCT01148654?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.