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.

Study Overview

• Status: Completed
• Conditions: Health Problems in Pregnancy

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 Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • University of Tennessee Health Science Center, OB-GYN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: University of Tennessee
• Collaborators: 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 record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 25, 2020
• Study Completion (Actual): June 25, 2020

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 14-03383-XP