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NCT02505464 Clinical Trial

Pregnancies Complicated by Fetal Anomalies

Pregnancy Clinical Trial

— FAR  

Official title:
Characteristics of Pregnancies Complicated by Fetal Anomalies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02505464
Other study ID # 15-03804-XP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2015
Est. completion date April 2026

Study information
Verified date October 2023
Source University of Tennessee
Contact Norman Meyer, M.D.
Phone 901-448-2531
Email nmeyer@uthsc.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

Description:

1. Repository data will be collected from the medical record and entered into the data base after the patient has completed the appointment. 2. Data collection will continue into the postpartum period for each participant. 3. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date April 2026
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 1 Minute to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States LeBonheur Children's Hospital Memphis Tennessee
United States Methodist LeBonheur Healthcare, LeBonheur Fetal Center Memphis Tennessee
United States Regional One Health Center for High Risk Pregnancies Memphis Tennessee
United States Regional One Health, OB/GYN Clinic, Maternal Fetal Medicine Memphis Tennessee
United States Regional One Health, Regional Medical Center, Rout Center for Women and Children Memphis Tennessee

Sponsors (2)
Lead Sponsor Collaborator
University of Tennessee Regional One Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Data Collection Data collection from participant's medical records will be entered into a data base From the initial visit @ the High Risk Clinic through the infants approx. age of 6 months
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