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Early Identification of Brain Insult in Chorioamnionitis

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01778725
Enrollment
90
Registered
2013-01-29
Start date
2013-01-31
Completion date
Unknown
Last updated
2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Chorioamnionitis

Keywords

Chorioamnionitis, S100B, Brain, Neuro-development

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.

Interventions

None listed

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Developmental assessment18 monthDevelopmental assessment at 18 month 1. Vineland Adaptive Behavior Scales 2. Griffith Mental Development Scales

Countries

Israel

Contacts

Primary ContactOmer Bar - Yosef, M.D.- Ph.D.
omerbary@gmail.com972-52-6667344

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026