Can Non-invasive Sampling Determine the Inflammatory Status of the Intra-uterine Environment?

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01090583
First received: March 18, 2010
Last updated: March 19, 2010
Last verified: March 2010
  Purpose

Preterm birth (birth before 37 weeks gestation) is a large problem in the United States and is a major cause of neonatal morbidity and mortality and childhood neurological disability. Despite significant advances in the care of pregnant mothers, the incidence of preterm labor is on the rise. There is growing recognition that cytokines and inflammatory mediators present at amniotic fluid and placenta play a fundamental role in regulating labor.

Cytokines are chemicals in the fluid that tell the body's immune system what to do. These (and other biomarkers) can be measured with a small amount (a few drops) of amniotic fluid. The researchers have previously shown that people at risk for preterm labor have higher cytokine levels. However, understanding the in-utero environment currently requires invasive sampling, such as amniocentesis, to determine cytokine concentrations. This procedure has inherent risks, causes patient discomfort and anxiety, and thus does not avail itself to routine use or repeated sampling, especially in non-high risk patients. Therefore, the researchers are looking for non-invasive sampling that can predict the in-utero environment.

To date, no studies have simultaneously evaluated different maternal-fetal compartments to determine the relationship of these markers among the compartments. Therefore, the purpose of this pilot study is to determine the differential expression of inflammatory mediators in various maternal-fetal compartments; specifically, vaginal fluid, cervical secretions, placenta, cord blood (arterial and venous), amniotic fluid, maternal serum, maternal urine, and maternal saliva.

The researchers seek to obtain fluid samples from nine maternal-fetal compartments and determine the inflammatory mediator expression in each. The timing of collection, location, and proposed studies for each of the samples is outlined in Table 1. In this pilot study, we plan to enroll 20 patients undergoing cesarean delivery.

After consent, the samples will be collected and given a unique Study ID number. No protected health information will be collected. In addition, there will be no link between the Study ID and patient identifiers. Therefore, we are not seeking HIPAA authorization at the time of consent. While none of these samples would routinely be collected as part of the standard of care, the collection procedures meet the criteria for minimal risk.


Condition Intervention
Pregnancy
Other: Specimen Collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Non-invasive Sampling Determine the Inflammatory Status of the Intra-uterine Environment?

Further study details as provided by Winthrop University Hospital:

Biospecimen Description:

observational study, no specimens required.


Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cesarean Delivery Patients Other: Specimen Collection
We will compare mediators from non-invasive samples (blood, urine, saliva, vaginal or cervical secretions) with traditional gold-standard invasive samples (amniotic fluid and placenta samples).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The researchers seek to obtain fluid samples from nine maternal-fetal compartments and determine the inflammatory mediator expression in each. These mediators include cytokines, chemokines, and growth factors via the Bio-Plex™ Suspension Array system. In this study, we plan to enroll 20 patients undergoing cesarean delivery at term.

Criteria

Inclusion Criteria:

  • Undergoing cesarean delivery
  • Able to provide informed consent, including permission of storage of specimens
  • No apparent major fetal abnormality

Exclusion Criteria:

  • Major Fetal Malformation
  • Rupture of membranes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090583

Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Nazeeh Hanna, MD Winthrop University Hospital
  More Information

No publications provided

Responsible Party: Nazeeh Hanna, M.D., Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01090583     History of Changes
Other Study ID Numbers: 09042
Study First Received: March 18, 2010
Last Updated: March 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Cytokines
Pregnancy
Cesarean

ClinicalTrials.gov processed this record on July 24, 2014