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Clinical Trials/NCT01778725
NCT01778725
Unknown
N/A

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

Sheba Medical Center1 site in 1 country90 target enrollmentJanuary 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chorioamnionitis
Sponsor
Sheba Medical Center
Enrollment
90
Locations
1
Primary Endpoint
Developmental assessment
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
August 2015
Last Updated
13 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Developmental assessment

Time Frame: 3 month

Developmental assessment at term and 3 month 1. Neurological examination 2. Test of infant motor performance

Study Sites (1)

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