Obstetrical Repository of Biological Materials
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.
研究概览
地位
条件
详细说明
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).
研究类型
注册 (实际的)
联系人和位置
学习地点
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Tennessee
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Memphis、Tennessee、美国、38103
- University of Tennessee Health Science Center, OB-GYN
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- English speaking female
- patients presenting for medical care at the Regional One Health perinatal clinics or Regional One Health Labor and Delivery Dept. will be asked to participate in the study.
Exclusion Criteria:
- Those not meeting the above criteria.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Maternal biological sample collection for repository
大体时间:On average, samples will be collected up to 42 wks of pregnancy & also at time of delivery.
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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.
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On average, samples will be collected up to 42 wks of pregnancy & also at time of delivery.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Stillborn fetal sample collection for repository
大体时间: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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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.
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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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合作者和调查者
调查人员
- 首席研究员: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
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 14-03383-XP
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