The Biomarker Study

This study has been completed.
Sponsor:
Collaborator:
March of Dimes
Information provided by (Responsible Party):
Michal A. Elovitz, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01148654
First received: June 18, 2010
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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.


Condition
Preterm Birth
Preterm Labor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Preterm Birth and Adverse Neonatal Outcomes With Novel Biomarkers: Identifying Those at Greatest Risk to Allow for Future Therapeutic Trials

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • preterm birth [ Time Frame: enrollment through delivery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

maternal serum, plasma, saliva; Neonatal saliva


Enrollment: 1076
Study Start Date: May 2008
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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. Group 2: 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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148654

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
March of Dimes
Investigators
Principal Investigator: Michal A Elovitz, MD University of Pennsylvania
Principal Investigator: Jamie A Bastek, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Michal A. Elovitz, Associate Professor, Director, Maternal and Child Health Research Program, Department of Obstetrics and Gynecology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01148654     History of Changes
Other Study ID Numbers: 807678
Study First Received: June 18, 2010
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
preterm birth
preterm labor
PTB
PTL

Additional relevant MeSH terms:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on April 15, 2014