Early Identification of Brain Insult in Chorioamnionitis

Overview

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.

Full Title of Study: “S100B as a Marker for Fetal Brain Injury in Premature Rupture of Membranes”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2015

Clinical Trial Outcome Measures

Primary Measures

  • Developmental assessment
    • Time Frame: 18 month
    • Developmental assessment at 18 month Vineland Adaptive Behavior Scales Griffith Mental Development Scales
  • Developmental assessment
    • Time Frame: 3 month
    • Developmental assessment at term and 3 month Neurological examination Test of infant motor performance

Participating in This Clinical Trial

Inclusion Criteria

  • Rupture of the amniotic sac before 32 weeks – Gestational age less than 32 weeks – Singleton Exclusion Criteria:

  • Intrauterine growth restriction – Positive TORCH – Fetus' brain malformation – Fetus' brain hemorrhage – Maternal medication with teratogenic effect

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sheba Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Boaz Weisz, M.D., Principal Investigator, Chaim Sheba Medical Center
  • Overall Contact(s)
    • Omer Bar – Yosef, M.D.- Ph.D., 972-52-6667344, omerbary@gmail.com

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