Early Identification of Brain Insult in Chorioamnionitis
- Conditions
- Cerebral PalsyChorioamnionitis
- Registration Number
- NCT01778725
- Lead Sponsor
- Sheba Medical Center
- 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 Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 90
- Rupture of the amniotic sac before 32 weeks
- Gestational age less than 32 weeks
- Singleton
- Intrauterine growth restriction
- Positive TORCH
- Fetus' brain malformation
- Fetus' brain hemorrhage
- Maternal medication with teratogenic effect
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Developmental assessment 3 month Developmental assessment at term and 3 month
1. Neurological examination
2. Test of infant motor performance
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chaim Seba Medical Center
🇮🇱Ramat-Gan, Israel