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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02996279
Other study ID # 100093
Secondary ID
Status Completed
Phase N/A
First received November 25, 2016
Last updated December 14, 2016
Start date February 2012
Est. completion date March 2013

Study information

Verified date December 2016
Source Catholic University of the Sacred Heart
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS) and increased levels of proinflammatory molecules.


Description:

Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS). The aim of this pilot study was to evaluate S100A12, a marker of innate immune activation, in mothers with or without HCA and in their infants.

Concentrations of S100A12, Interleukin 6 (IL-6) and C-reactive protein (CRP) were evaluated in maternal, cord, and neonatal blood of very preterm infants. Histologic examinations of placentae and umbilical cords were performed.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date March 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

Preterm Birth

Exclusion Criteria:

Congenital Abnormalities

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart

Outcome

Type Measure Description Time frame Safety issue
Primary S100A12 in Presence of Maternal Chorioamnionitis Levels of S100A12 in Maternal, Cord and Neonatal Blood in the Presence or Absence of HCA 1 Year No