Health Problems in PregnancyNCT02429362
Obstetrical Repository of Biological Materials
An observational study of Health Problems in Pregnancy, run by University of Tennessee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Problems in Pregnancy
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 25 Jun 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Those not meeting the above criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center, OB-GYN
Memphis, Tennessee, 38103
About this study
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.
Read the 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).
- Conditions
- Health Problems in Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startMay 2015
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Problems in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Regional One Health, University of Tennessee Regional One Physicians
- Responsible party
- Sponsor
- Investigators
- Giancarlo Mari, M.D., Principal investigator, Prof. & Chair, UTHSC; Dir.,TN Inst. of Feto-Maternal & Infant Health; Dir., High-Risk Obstetrics Ctr of Excell., Regional Medical Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429362
- Sponsor's protocol ID
- 14-03383-XP
- Status last verified
- Nov 2020
- First submitted
- 20 Apr 2015
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetrical Repository of Biological Materials
- ClinicalTrials.gov ID
- NCT02429362
- Acronym / sponsor ID
- 14-03383-XP
- Conditions
- Health Problems in Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Regional One Health, University of Tennessee Regional One Physicians
- Study start
- May 2015
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Those not meeting the above criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal biological sample collection for repository
Time frame: 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.
1 secondary outcome
Stillborn fetal sample collection for repository
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
Related trials for Health Problems in Pregnancy
Recruiting
E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families
Preterm Birth
Active, not recruiting
Interdisciplinary E-health Based Follow-up of Preterm Born Children
Preterm Birth
Active, not recruitingObservational study
JiGenerations Health Cohort Study：Parental Exposure and Intergenerational Health in China
Environmental Exposure, Fertility
RecruitingObservational study
Peking University Birth Cohort in Weifang (PKUBC-WF)
Health Problems in Pregnancy, Pregnancy Outcomes
Enrolling by invitation
Counseling for Alcohol Problems in Pregnancy (CAP-Pre) Phase II
Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giancarlo Mari, M.D. principal investigator
Prof. & Chair, UTHSC; Dir.,TN Inst. of Feto-Maternal & Infant Health; Dir., High-Risk Obstetrics Ctr of Excell., Regional Medical Ctr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Problems in Pregnancy, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal biological sample collection for repository (time frame: On average, samples will be collected up to 42 wks of pregnancy & also at time of delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.