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
  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 ] [ 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


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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01778725     History of Changes
Other Study ID Numbers: SHEBA-12-9616-BW-CTIL
Study First Received: November 25, 2012
Last Updated: January 25, 2013
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on September 18, 2014