The Biomarker Study

NCT ID: NCT01148654

Last Updated: 2014-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1076 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-06-30

Brief 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 maternal blood at up to four occasions, small samples of placental cord blood, a maternal saliva sample, and an infant buccal swab. We will follow each of these patient's pregnancy outcomes, and determine if there are any correlations between levels of certain biomarkers and latency to delivery as well as composite adverse neonatal outcomes. In women with PTB < 37 weeks, cord blood will be collected (as well as maternal saliva and an infant buccal swab) and biomarkers compared between those infants with and without specific adverse neonatal outcomes. Maternal saliva and buccal will be collected on all women and infants enrolled.

Conditions

Preterm Birth; Preterm Labor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1- Preterm Labor 22.0-33.6 weeks gestational age

Pregnant women between 22.0 and 33.6 weeks gestational age presenting to the Hospital of the University of Pennsylvania (HUP) complaining of Preterm labor (PTL), preterm premature rupture of membranes (PPROM), or cervical insufficiency (CI).

No interventions assigned to this group

2- Preterm birth 34-36.6 weeks gestational age

Pregnant women delivering at the University of Pennsylvania between 34.0 and 36.6 weeks gestational age

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Women with singleton pregnancies between 22-0/7 and 33-6/7 weeks gestational age who present to the Hospital of the University of Pennsylvania 'Perinatal Evaluation Center' (PEC) complaining of PTL, PPROM, or CI.
• Women who present to Labor and Delivery and will deliver (or have just delivered) a single infant preterm (22-0/7 to 36-6/7 weeks) at HUP.

Exclusion Criteria

• Multiple-gestation, major fetal anomaly, fetal demise, severe preeclampsia prior to enrollment, patients on chronic steroid use or immunosuppressive drugs, patients with significant (active) immunological disease (AIDS, SLE), acute febrile illness (such as with active influenza or pyelonephritis), and pregestational diabetes.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

March of Dimes

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Michal A. Elovitz

Associate Professor, Director, Maternal and Child Health Research Program, Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michal A Elovitz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Jamie A Bastek, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

807678

Identifier Type: -

Identifier Source: org_study_id