Can Non-invasive Sampling Determine the Inflammatory Status of

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Pregnancy

Clinical Trial Details

NCT number	NCT01090583
Study type	Observational
Source	Winthrop University Hospital
Contact
Status	Completed
Phase	N/A
Start date	March 2010
Completion date	July 2010

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms