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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.