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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01778725
Other study ID # SHEBA-12-9616-BW-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 25, 2012
Last updated January 25, 2013
Start date January 2013

Study information

Verified date January 2013
Source Sheba Medical Center
Contact Omer Bar - Yosef, M.D.- Ph.D.
Phone 972-52-6667344
Email omerbary@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Chaim Seba Medical Center Ramat-Gan

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Developmental assessment Developmental assessment at 18 month
Vineland Adaptive Behavior Scales
Griffith Mental Development Scales
18 month No
Primary Developmental assessment Developmental assessment at term and 3 month
Neurological examination
Test of infant motor performance
3 month No
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