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.
연구 개요
상태
정황
상세 설명
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).
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Tennessee
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Memphis, Tennessee, 미국, 38103
- University of Tennessee Health Science Center, OB-GYN
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maternal biological sample collection for repository
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Stillborn fetal sample collection for repository
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: 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
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 14-03383-XP
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .