Cerebral Palsy Clinical Trial
Official title:
S100B as a Marker for Fetal Brain Injury in Premature Rupture of Membranes
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.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | Chaim Seba Medical Center | Ramat-Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Developmental assessment | Developmental assessment at 18 month Vineland Adaptive Behavior Scales Griffith Mental Development Scales |
18 month | No |
Primary | Developmental assessment | Developmental assessment at term and 3 month Neurological examination Test of infant motor performance |
3 month | No |
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