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Obstetrical Repository of Biological Materials

2020年11月11日 更新者:University of Tennessee

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

完全的

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

观察性的

注册 (实际的)

1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Tennessee
      • Memphis、Tennessee、美国、38103
        • University of Tennessee Health Science Center, OB-GYN

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

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

是的

有资格学习的性别

女性

取样方法

概率样本

研究人群

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.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

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
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.
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.

次要结果测量

结果测量
措施说明
大体时间
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.
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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年5月1日

初级完成 (实际的)

2020年6月25日

研究完成 (实际的)

2020年6月25日

研究注册日期

首次提交

2015年4月20日

首先提交符合 QC 标准的

2015年4月23日

首次发布 (估计)

2015年4月29日

研究记录更新

最后更新发布 (实际的)

2020年11月13日

上次提交的符合 QC 标准的更新

2020年11月11日

最后验证

2020年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 14-03383-XP

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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