Clinical Trial: Early Identification of Brain Insult in Chorioamnionitis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: S100B as a Marker for Fetal Brain Injury in Premature Rupture of Membranes

Brief Summary:

Premature breaking of the amniotic fluids during pregnancy caries high risk for infection of the amniotic fluid. One of the results of chorioamnionitis is brain injury of the fetus. Fetus' brain is highly vulnerable and could be harmed even by mild inflammation before fulminant infection is developed. The aim of this study is to identify, as early as, possible signs of brain injury. S100B protein will be used as a marker for brain insult. S100b level were associated with the occurrence and size of stroke and brain trauma in adults and children. Moreover, S100B crosses the membrane and its level in women with preterm labor was associated with brain injury of preterm infant.

The study question is whether the levels of S100B in women with early amniotic fluids breakdown are associated with future brain injury of the infant, as assessed by head ultrasound and neurological examination.


Detailed Summary:
Sponsor: Sheba Medical Center

Current Primary Outcome:

  • Developmental assessment [ Time Frame: 18 month ]

    Developmental assessment at 18 month

    1. Vineland Adaptive Behavior Scales
    2. Griffith Mental Development Scales
  • Developmental assessment [ Time Frame: 3 month ]

    Developmental assessment at term and 3 month

    1. Neurological examination
    2. Test of infant motor performance


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sheba Medical Center

Dates:
Date Received: November 25, 2012
Date Started: January 2013
Date Completion:
Last Updated: January 25, 2013
Last Verified: January 2013