Pregnancies Complicated by Fetal Anomalies (FAR)

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Abnormalities; Pregnancy

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Annette B. Hickerson, R.N., CCRC; Phone Number: 901-448-4784; Email: abpayne@uthsc.edu
• Study Contact Backup: Name: Norman Meyer, M.D.; Phone Number: 901-448-2531; Email: nmeyer@uthsc.edu

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Recruiting
      • LeBonheur Children's Hospital
      • Contact: Annette B. Hickerson, RN, CCRc; Phone Number: 901-448-4784; Email: abpayne@uthsc.edu
    • Memphis, Tennessee, United States, 38103
      • Recruiting
      • Methodist LeBonheur Healthcare, LeBonheur Fetal Center
      • Contact: Annette B. Hickerson, RN, CCRc; Phone Number: 901-448-4784; Email: abpayne@uthsc.edu
    • Memphis, Tennessee, United States, 38103
      • Recruiting
      • Regional One Health, OB/GYN Clinic, Maternal Fetal Medicine
      • Contact: Annette B. Hickerson, R.N.; Phone Number: 901-448-4784; Email: abpayne@uthsc.edu
    • Memphis, Tennessee, United States, 38103
      • Recruiting
      • Regional One Health, Regional Medical Center, Rout Center for Women and Children
      • Contact: Annette B. Hickerson, RN, CCRc; Phone Number: 901-448-4784; Email: abpayne@uthsc.edu
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Regional One Health Center for High Risk Pregnancies
      • Contact: Annette B. Hickerson, R.N.; Phone Number: 901-448-4784; Email: abpayne@uthsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Tennessee
• Collaborators: Regional One Health
• Investigators: Principal Investigator: Norman Meyer, M.D., Vice-Chair and Professor, MFM Fellowship Director Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (Estimated): July 22, 2015

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 15-03804-XP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED