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Early Identification of Brain Insult in Chorioamnionitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01778725
First Posted: January 29, 2013
Last Update Posted: January 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
  Purpose

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.


Condition
Chorioamnionitis Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: S100B as a Marker for Fetal Brain Injury in Premature Rupture of Membranes

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Developmental assessment [ Time Frame: 18 month ]

    Developmental assessment at 18 month

    1. Vineland Adaptive Behavior Scales
    2. Griffith Mental Development Scales

  • Developmental assessment [ Time Frame: 3 month ]

    Developmental assessment at term and 3 month

    1. Neurological examination
    2. Test of infant motor performance


Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with premature rupture of the amniotic sac.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778725


Contacts
Contact: Omer Bar - Yosef, M.D.- Ph.D. 972-52-6667344 omerbary@gmail.com

Locations
Israel
Chaim Seba Medical Center Not yet recruiting
Ramat-Gan, Israel, 56210
Principal Investigator: Boaz Weisz, M.D.         
Sub-Investigator: Omer Bar-Yosef, M.D.-Ph.D.         
Sub-Investigator: Yoav Yinon, M.D.         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Boaz Weisz, M.D. Chaim Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01778725     History of Changes
Other Study ID Numbers: SHEBA-12-9616-BW-CTIL
First Submitted: November 25, 2012
First Posted: January 29, 2013
Last Update Posted: January 29, 2013
Last Verified: January 2013

Keywords provided by Sheba Medical Center:
Chorioamnionitis, S100B, Brain, Neuro-development

Additional relevant MeSH terms:
Cerebral Palsy
Chorioamnionitis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Fetal Diseases
Pregnancy Complications
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Placenta Diseases