Pregnancies Complicated by Fetal Anomalies

Recruiting

• Conditions: Pregnancy; Congenital Abnormalities

• Registration Number: NCT02505464
• Lead Sponsor: University of Tennessee

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.

Detailed 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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2027-05
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data Collection	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

Trial Locations

Locations (5)

LeBonheur Children's Hospital; 🇺🇸 Memphis, Tennessee, United States

Methodist LeBonheur Healthcare, LeBonheur Fetal Center; 🇺🇸 Memphis, Tennessee, United States

Regional One Health, OB/GYN Clinic, Maternal Fetal Medicine; 🇺🇸 Memphis, Tennessee, United States

Regional One Health Center for High Risk Pregnancies; 🇺🇸 Memphis, Tennessee, United States

Regional One Health, Regional Medical Center, Rout Center for Women and Children; 🇺🇸 Memphis, Tennessee, United States