Early Identification of Brain Insult in Chorioamnionitis
| Tracking Information | |||||
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| First Received Date ICMJE | November 25, 2012 | ||||
| Last Updated Date | January 25, 2013 | ||||
| Start Date ICMJE | January 2013 | ||||
| Estimated Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01778725 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Identification of Brain Insult in Chorioamnionitis | ||||
| Official Title ICMJE | S100B as a Marker for Fetal Brain Injury in Premature Rupture of Membranes | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Pregnant women with premature rupture of the amniotic sac. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 90 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01778725 | ||||
| Other Study ID Numbers ICMJE | SHEBA-12-9616-BW-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sheba Medical Center | ||||
| Study Sponsor ICMJE | Sheba Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Sheba Medical Center | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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