PregnancyFARNCT02505464
Pregnancies Complicated by Fetal Anomalies
An observational study of Pregnancy and Congenital Abnormalities, run by University of Tennessee at 5 sites in United States.
Trial summary
The focus of this research is to create a repository of ultrasonographic images and their corresponding medical data from pregnant women (the mothers of the fetuses that are imaged), focusing on fetal anomalies. These women will visit the obstetrical clinics at Regional One Health and the Le Bonheur Fetal Center. Read more about this study
- Who is it for?
- Ages 1 minute to 50 years
- Conditions the study is for
- Pregnancy, Congenital Abnormalities
- How many people
- 500 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2015to Apr 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 minute to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients referred to, or being seen in the Ob-Gyn High Risk Clinics (ROH-MFM Clinic, ROH-CHRP, ROH-Rout Center, Le Bonheur Fetal Center) will be potential participants.
Who may be able to join
- Pregnant females
- age 8 years to 50 years
- who have referred to the clinic for high risks pregnancies
- Infants (male and female) born with anomalies
Who cannot join
- Non-pregnant females.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
LeBonheur Children's Hospital
Memphis, Tennessee, 38103
Annette B. Hickerson, RN, CCRC, 901-448-4784, abpayne@uthsc.edu
- Recruiting
Methodist LeBonheur Healthcare, LeBonheur Fetal Center
Memphis, Tennessee, 38103
Annette B. Hickerson, RN, CCRC, 901-448-4784, abpayne@uthsc.edu
- Recruiting
Regional One Health, OB/GYN Clinic, Maternal Fetal Medicine
Memphis, Tennessee, 38103
Annette B. Hickerson, R.N., 901-448-4784, abpayne@uthsc.edu
- Recruiting
Regional One Health, Regional Medical Center, Rout Center for Women and Children
Memphis, Tennessee, 38103
Annette B. Hickerson, RN, CCRc, 901-448-4784, abpayne@uthsc.edu
- Recruiting
Regional One Health Center for High Risk Pregnancies
Memphis, Tennessee, 38120
Annette B. Hickerson, R.N., 901-448-4784, abpayne@uthsc.edu
About this study
Official title: Characteristics of Pregnancies Complicated by Fetal Anomalies
The focus of this research is to create a repository of ultrasonographic images and their corresponding medical data from pregnant women (the mothers of the fetuses that are imaged), focusing on fetal anomalies. These women will visit the obstetrical clinics at Regional One Health and the Le Bonheur Fetal Center.
Read the detailed description
- Repository data will be collected from the medical record and entered into the data base after the patient has completed the appointment.
- Data collection will continue into the postpartum period for each participant.
- Data collection will continue for the child during the treatment of the medical condition, up to approximately 6 months of age if required by the condition.
- Conditions
- Pregnancy, Congenital Abnormalities
- Medical subject headings
- Congenital Abnormalities
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 fetuses/infants | Information about pregnant women and their fetuses/infants, including the medical history, prenatal, perinatal, and postpartum periods (6 weeks after delivery) and throughout the treatment (e.g.surgery) for the child's medical condition (up to approx. child is @ 6 months of age), will be collected in this repository. The analysis of this information may help in understanding of the causes of fetal anomalies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection
Data collection from participant's medical records will be entered into a data base
Measured: From the initial visit @ the High Risk Clinic through the infants approx. age of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Regional One Health
- Responsible party
- Sponsor
- Investigators
- Norman Meyer, M.D., Principal investigator, Vice-Chair and Professor, MFM Fellowship Director Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505464
- Sponsor's protocol ID
- 15-03804-XP
- Acronym
- FAR
- Status last verified
- Dec 2024
- First submitted
- 6 Jul 2015
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Pregnancies Complicated by Fetal Anomalies
- ClinicalTrials.gov ID
- NCT02505464
- Acronym / sponsor ID
- FAR / 15-03804-XP
- Conditions
- Pregnancy, Congenital Abnormalities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Regional One Health
- Study start
- May 2015 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 Jul 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.
The focus of this research is to create a repository of ultrasonographic images and their corresponding medical data from pregnant women (the mothers of the fetuses that are imaged), focusing on fetal anomalies. These women will visit the obstetrical clinics at Regional One Health and the Le Bonheur Fetal Center.
Detailed description
- Repository data will be collected from the medical record and entered into the data base after the patient has completed the appointment.
- Data collection will continue into the postpartum period for each participant.
- Data collection will continue for the child during the treatment of the medical condition, up to approximately 6 months of age if required by the condition.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women & their fetuses/infants | – | –Information about pregnant women and their fetuses/infants, including the medical history, prenatal, perinatal, and postpartum periods (6 weeks after delivery) and throughout the treatment (e.g.surgery) for the child's medical condition (up to approx. child is @ 6 months of age), will be collected in this repository. The analysis of this information may help in understanding of the causes of fetal anomalies. |
Who may qualify
- Ages
- 1 minute to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients referred to, or being seen in the Ob-Gyn High Risk Clinics (ROH-MFM Clinic, ROH-CHRP, ROH-Rout Center, Le Bonheur Fetal Center) will be potential participants.
Key inclusion criteria (4 listed)
- Pregnant females
- Infants (male and female) born with anomalies
Key exclusion criteria (1 listed)
- Non-pregnant females.
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
Data Collection
Time frame: From the initial visit @ the High Risk Clinic through the infants approx. age of 6 months
Data collection from participant's medical records will be entered into a data base
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Norman Meyer, M.D. principal investigator
Vice-Chair and Professor, MFM Fellowship Director Obstetrics and Gynecology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Congenital Abnormalities, run by University of Tennessee at 5 sites 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 4 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norman Meyer, M.D. (901-448-2531, nmeyer@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collection (time frame: From the initial visit @ the High Risk Clinic through the infants approx. age of 6 months). 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 9 Dec 2024.