- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01148654
The Biomarker Study
Predicting Preterm Birth and Adverse Neonatal Outcomes With Novel Biomarkers: Identifying Those at Greatest Risk to Allow for Future Therapeutic Trials
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
preterm birth
Time Frame: enrollment through delivery
|
enrollment through delivery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jamie A Bastek, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 807678
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Preterm Birth
-
e-Bio CorpRecruitingPreterm Labor | PreTerm Birth | Preterm Labor With Delivery NosUnited States
-
Thomas Jefferson UniversityCompleted
-
PreTeL, IncDuke University; University of RochesterRecruitingPreterm Birth | Threatened Preterm Labor | PreTerm LaborUnited States
-
Chelsea and Westminster NHS Foundation TrustSPD Development Company Limited; Borne CharityRecruitingPreterm Birth | Preterm Labor | Preterm Birth Complication | Preterm Premature Rupture of Membrane | Preterm PregnancyUnited Kingdom
-
Cairo UniversityCompleted
-
University of OklahomaCompletedPreTerm Birth | PreTerm NeonateUnited States
-
Federico II UniversityRecruiting
-
University of OxfordShoklo Malaria Research UnitCompleted
-
Eunice Kennedy Shriver National Institute of Child...CompletedPregnancy | Preterm Birth | Preterm LaborUnited States
-
University Hospital Inselspital, BerneAmniSure International LLCCompletedPreterm Birth | Preterm LabourSwitzerland