Obstetrical Repository of Biological Materials

NCT02429362 | Completed

• 1 other identifier: 14-03383-XP
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Problems in Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

Study Arms (1)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Those not meeting the above criteria.

Sponsors & Collaborators

• University of Tennessee: lead
• Regional One Health: collaborator
• University of Tennessee Regional One Physicians: collaborator

Study Sites (1)

University of Tennessee Health Science Center, OB-GYN

Memphis, Tennessee, 38103, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sample collections for purposes of: understanding of normal events in pregnancy; disease conditions of the woman/baby during pregnancy; and future use in studies to develop cell lines for research, create tests to diagnose disease, or develop treatments.

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 29, 2015
• Study Start: May 1, 2015
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

US (1)