Clinical trial NCT02317315: Biomarkers Associated With Spontaneous Preterm Birth Less Than 32 Wks Gestation
Official title: Non-Invasive Sampling of Inflammatory Mediators Associated With Spontaneous Preterm Birth Less Than 32 Weeks Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Labor
Preterm Birth
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2014-12-16
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant females between the age of 18-40 who present in preterm labor will be asked to participate.

Brief summary: Preterm delivery (PTD) is a leading cause of neonatal mortality and continues to be a major public health concern, reaching 12.9% in 2006, despite intense research to reverse this trend. Currently, fetal fibronectin (fFN) screening and cervical length determined by ultrasound are two tests which are proven to have benefit in the identification of those at greatest risk for preterm delivery. However the benefit of these tests is limited to situations where a negative result can avoid unnecessary interventions. Currently, maternal fetal monitoring is limited, as it is difficult to "see" what is going on in the placenta (maternal-fetal interface) without invasive measures such as placental biopsy or amniocentesis. Our goal for this study is to identify a group of biomarkers in non-invasive compartments (such as saliva, blood, urine, and/or cervical and vaginal secretions) that are associated with preterm labor and birth. We hypothesize that preterm labor will display an inflammatory profile, which consists of unique inflammatory biomarkers from different non-invasive bodily fluid compartments (such as Il-10 in urine, VEGF in cervical secretions, and IP-10 in saliva), that correlates with a high incidence of preterm birth.

Detailed description: Preterm delivery (PTD) is a leading cause of neonatal mortality and continues to be a major public health concern, reaching 12.9% in 2006, despite intense research to reverse this trend. Currently, fetal fibronectin (fFN) screening and cervical length determined by ultrasound are two tests which are proven to have benefit in the identification of those at greatest risk for preterm delivery. However the benefit of these tests is limited to situations where a negative result can avoid unnecessary interventions. The first goal of this study is to identify non-invasive predictor(s) that will increase the clinician's ability to identify patients who present with second trimester preterm labor (PTL) at risk for preterm delivery (PTD) ≤ 32 weeks gestation.

Currently, maternal fetal monitoring is limited, as it is difficult to "see" what is going on in the placenta (maternal-fetal interface) without invasive measures such as placental biopsy or amniocentesis. Our preliminary study from term pregnancies has shown that a specific correlation of an intrauterine cytokine may be reflected in one noninvasive site but not another, depending upon the type of cytokine and the compartment from which it is secreted. Therefore, our second goal for this study is to identify inflammatory markers in non-invasive maternal compartments (such as saliva, blood, urine, and/or cervical and vaginal secretions) that have a strong association with placenta/fetal membranes at the time of preterm birth ≤ 32 weeks gestation.

Pregnant women, under 32 weeks gestation, who are admitted to Winthrop University Hospital for evaluation of preterm labor will be eligible for this study. Women with indicated preterm births (i.e. pre-eclampsia), multiple pregnancies, known major fetal abnormality (ex. those that are known to be incompatible with life) and premature rupture of membranes will be excluded from this study. After consent is obtained, samples (blood, urine, saliva, vaginal, and cervical secretions) will be obtained and biomarkers will be identified using a Bio-Plex cytokine concentration assay. These women will than be followed until they deliver. Women who deliver after 32 weeks gestation will form our control group and women who deliver before 32 weeks gestation will form our preterm birth group. Concentration of the biomarkers in the various maternal-fetal compartments will be analyzed and compared between the two groups. For all women who delivery ≤ 32 weeks gestation, non-invasive samples will also be collected around delivery and these cytokine levels will be compared to placenta/fetal membranes to access how well non-invasive fluids reflect the intrauterine environment.

We hypothesize that preterm labor will display an inflammatory profile, which consists of unique inflammatory biomarkers from different non-invasive bodily fluid compartments (such as Il-10 in urine, VEGF in cervical secretions, and IP-10 in saliva), that correlates with a high incidence of preterm birth.

Eligibility criteria: Inclusion Criteria:

* Pregnant women age 18-40 years old between 20 to 32 weeks gestation with singleton pregnancies and are admitted to Winthrop University Hospital for evaluation of preterm labor. Preterm labor will be defined as contractions every 5 minutes associated with cervical changes or cervical dilatation \> 2cm with 80% effacement. Subjects must have reliable dates confirmed by early ultrasound.

Exclusion Criteria:

* Indicated preterm births (i.e. pre-eclampsia), multiple pregnancies, known major fetal abnormality (ex. those that are known to be incompatible with life) and premature rupture of membranes.

Primary outcomes:
measure: Gestational age at delivery
timeFrame: Within 5 months of Preterm labor
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hosptial
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: RANJITH KAMITY, MD
role: PRINCIPAL_INVESTIGATOR
References: