Biomarkers Associated With Spontaneous Preterm Birth Less Than 32 Wks Gestation

NCT02317315 | Completed DMC

• 1 other identifier: WinthropUH
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor; Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Gestational age at delivery

  Within 5 months of Preterm labor

Study Arms (1)

Preterm labor group

Patients who are admitted for evaluation of preterm labor.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ranjith Kamity, MD: lead

Study Sites (1)

Winthrop University Hosptial

Mineola, New York, 11501, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Saliva - We will collect saliva in a sterile container. 2. Maternal Blood - Blood samples will be collected during routine blood draws and into serum separator tubes, spun, and the serum stored at -80°C. 3. Urine - Urine samples will be collected into a sterile container. 4. Cervical and vaginal secretions - During speculum exam, we will simultaneously insert two Weck-Cell Sponges directly into the cervical os for collection of cervical secretions then another two sponges will be applied in the posterior fornix for collection of vaginal fluid.

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• RANJITH KAMITY, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 16, 2014
• Study Start: January 1, 2013
• Primary Completion: January 2, 2016
• Study Completion: September 7, 2017
• Last Updated: January 29, 2018

Record last verified: 2018-01

Locations

US (1)