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| Name | Class |
|---|---|
| Regional One Health | OTHER |
| University of Tennessee Regional One Physicians | UNKNOWN |
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Subjects are being asked to donate blood, urine, vaginal secretions and/or tissue to a repository for research.This repository will store donated specimens for future research. The Department of Obstetrics and Gynecology at the University of Tennessee Health Science Center, under the direction of Dr. Giancarlo Mari, Professor and Chair, is responsible for the operation of the repository.
Additionally, in the case of a stillborn child, the mother will be given the opportunity to donate samples from her stillborn baby's autopsy to a repository for research.
The stored samples will be used in studies to help researchers understand normal events in pregnancy, as well as events that occur when women and/or their babies have a disease or condition during pregnancy. Additionally, the samples may be used in future studies to develop cell lines for research, create tests to diagnose disease, or develop treatments. A cell line is the result of cells grown outside the body in a laboratory. This process will allow those cells to grow continuously when given the appropriate nutrients and conditions for growth, and will result in a permanent cell culture which is the collection of cells that are grown outside the body in a laboratory.
The stored samples will also be used in future studies to help researchers identify genetic influences during pregnancy. Genes are like blueprints in each of your cells that determine traits that you inherit, like eye color and hair color. Genes may also influence what diseases you get and how you respond to treatment. DNA is the substance that makes up your genes.
The subject will sign an informed consent for her participation (Primary Informed Consent). In the situation of a stillbirth occurring, the mother of the stillborn baby will sign an informed consent regarding the tissue samples to be obtained during the hospital's routinely performed autopsy. (Secondary Informed Consent).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Women & their stillborn infants | All English speaking female patients who are seen in the Regional One Health perinatal clinics and/or deliver at Regional One Health are the group of study's focus. Likewise, when a delivery results in a stillbirth, the stillborn baby will also be an additional group of our study's focus. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maternal biological sample collection for repository | Outcomes will be assessed (including morbidity and mortality associated with the pregnancy/delivery). Studies of specimens may involve examinations for gross pathology, infection, or genomic/proteomic/metabolomic analyses. | On average, samples will be collected up to 42 wks of pregnancy & also at time of delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Stillborn fetal sample collection for repository | Outcomes will be assessed (including morbidity and mortality associated with the pregnancy/delivery). Studies of specimens may involve examinations for gross pathology, infection, or genomic/proteomic/metabolomic analyses. | At the occurence of a stillbirth, study samples will be collected from the stillborn baby following the hospital's stillborn autopsy policy, on average by the end of 1 week post delivery. |
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Inclusion Criteria:
Exclusion Criteria:
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All English speaking female patients who are seen in the Regional One Health perinatal clinics and/or deliver at Regional One Health will be asked to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Giancarlo Mari, M.D. | Prof. & Chair, UTHSC; Dir.,TN Inst. of Feto-Maternal & Infant Health; Dir., High-Risk Obstetrics Ctr of Excell., Regional Medical Ctr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Health Science Center, OB-GYN | Memphis | Tennessee | 38103 | United States |
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Sample collections for purposes of: understanding of normal events in pregnancy; disease conditions of the woman/baby during pregnancy; and future use in studies to develop cell lines for research, create tests to diagnose disease, or develop treatments.