Early Identification of Brain Insult in Chorioamnionitis
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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 |
- Developmental assessment [ Time Frame: 18 month ] [ Designated as safety issue: No ]
Developmental assessment at 18 month
- Vineland Adaptive Behavior Scales
- Griffith Mental Development Scales
- Developmental assessment [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Developmental assessment at term and 3 month
- Neurological examination
- 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 |
Pregnant women with premature rupture of the amniotic sac.
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| Contact: Omer Bar - Yosef, M.D.- Ph.D. | 972-52-6667344 | omerbary@gmail.com |
| 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. | |
| 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:
|
Cerebral Palsy Chorioamnionitis Fetal Membranes, Premature Rupture Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Fetal Diseases Pregnancy Complications Obstetric Labor Complications Placenta Diseases |
ClinicalTrials.gov processed this record on May 23, 2013