Chorioamnionitis and Proinflammatory S100A12

Chorioamnionitis Affecting Fetus or Newborn Clinical Trial

— S100A12  

Official title:

Impact of Chorioamnionitis on Maternal and Fetal Levels of Proinflammatory S100A12

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996279
• Other study ID #: 100093
• 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

• Chorioamnionitis
• Chorioamnionitis Affecting Fetus or Newborn

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