Early Identification of Brain Insult in Chorioamnionitis

NCT01778725 | Unknown

• 1 other identifier: SHEBA-12-9616-BW-CTIL
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chorioamnionitis; Cerebral Palsy

Keywords

Chorioamnionitis, S100B, Brain, Neuro-development

Outcome Measures

Primary Outcomes (2)

• Developmental assessment

  Developmental assessment at 18 month 1. Vineland Adaptive Behavior Scales 2. Griffith Mental Development Scales

  18 month

• Developmental assessment

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

  3 month

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with premature rupture of the amniotic sac.

You may qualify if:

• Rupture of the amniotic sac before 32 weeks
• Gestational age less than 32 weeks
• Singleton

You may not qualify if:

• Intrauterine growth restriction
• Positive TORCH
• Fetus' brain malformation
• Fetus' brain hemorrhage
• Maternal medication with teratogenic effect

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Chaim Seba Medical Center

Ramat Gan, 56210, Israel

Location

MeSH Terms

Conditions

Chorioamnionitis; Cerebral Palsy

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Boaz Weisz, M.D.

  Chaim Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omer Bar - Yosef, M.D.- Ph.D.

CONTACT

972-52-6667344; omerbary@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2012
• First Posted: January 29, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2015
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

IL (1)