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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090583
• Other study ID #: 09042
• Status: Completed
• Phase: N/A
• First received: March 18, 2010
• Last updated: December 8, 2014
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: December 2014
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Winthrop University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine Correlation		6 months	No