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Obstetrical Repository of Biological Materials

Sponsor
University of Tennessee (Other)
Overall Status
Completed
CT.gov ID
NCT02429362
Collaborator
Regional One Health (Other), University of Tennessee Regional One Physicians (Other)
1
Enrollment
1
Location
61.8
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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).

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Obstetrical Repository of Biological Materials
    Study Start Date :
    May 1, 2015
    Actual Primary Completion Date :
    Jun 25, 2020
    Actual Study Completion Date :
    Jun 25, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Maternal biological sample collection for repository [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.

    Secondary Outcome Measures

    1. Stillborn fetal sample collection for repository [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Tennessee Health Science Center, OB-GYN Memphis Tennessee United States 38103

    Sponsors and Collaborators

    • University of Tennessee
    • Regional One Health
    • University of Tennessee Regional One Physicians

    Investigators

    • Principal Investigator: 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Tennessee
    ClinicalTrials.gov Identifier:
    NCT02429362
    Other Study ID Numbers:
    • 14-03383-XP
    First Posted:
    Apr 29, 2015
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Nov 1, 2020

    Study Results

    No Results Posted as of Nov 13, 2020