Recruiting

Fetal Anomalies

Sponsor:

University of Tennessee

Code:

NCT02505464

Conditions

Pregnancy

Congenital Abnormalities

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Pregnancy

Congenital Abnormalities

Study ID

NCT02505464

Start date

May, 2015

Status verified date

Dec, 2024

Completion date

Apr, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non-pregnant females.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Data Collection [ Time Frame: From the initial visit @ the High Risk Clinic through the infants approx. age of 6 months ]

Central Contacts and Locations

Central contacts

Norman Meyer, M.D.

901-448-2531nmeyer@uthsc.edu

Annette B. Hickerson, R.N., CCRC

901-448-4784abpayne@uthsc.edu

Locations

LeBonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Annette B. Hickerson, RN, CCRC

901-448-4784abpayne@uthsc.edu

Methodist LeBonheur Healthcare, LeBonheur Fetal Center

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Annette B. Hickerson, RN, CCRC

901-448-4784abpayne@uthsc.edu

Regional One Health, OB/GYN Clinic, Maternal Fetal Medicine

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Annette B. Hickerson, R.N.

901-448-4784abpayne@uthsc.edu

Regional One Health, Regional Medical Center, Rout Center for Women and Children

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Annette B. Hickerson, RN, CCRc

901-448-4784abpayne@uthsc.edu

Regional One Health Center for High Risk Pregnancies

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Annette B. Hickerson, R.N.

901-448-4784abpayne@uthsc.edu

More Information

Sponsor

University of Tennessee

Last update posted

Dec 9, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2024-12-09.