Early Identification of Brain Insult in Chorioamnionitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01778725
First received: November 25, 2012
Last updated: January 25, 2013
Last verified: January 2013

November 25, 2012
January 25, 2013
January 2013
August 2015   (final data collection date for primary outcome measure)
  • Developmental assessment [ Time Frame: 18 month ] [ Designated as safety issue: No ]

    Developmental assessment at 18 month

    1. Vineland Adaptive Behavior Scales
    2. Griffith Mental Development Scales
  • Developmental assessment [ Time Frame: 3 month ] [ Designated as safety issue: No ]

    Developmental assessment at term and 3 month

    1. Neurological examination
    2. Test of infant motor performance
Same as current
Complete list of historical versions of study NCT01778725 on ClinicalTrials.gov Archive Site
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Early Identification of Brain Insult in Chorioamnionitis
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Pregnant women with premature rupture of the amniotic sac.

  • Chorioamnionitis
  • Cerebral Palsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
90
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August 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 55 Years
Yes
Contact: Omer Bar - Yosef, M.D.- Ph.D. 972-52-6667344 omerbary@gmail.com
Israel
 
NCT01778725
SHEBA-12-9616-BW-CTIL
No
Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Boaz Weisz, M.D. Chaim Sheba Medical Center
Sheba Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP