Pregnancies Complicated by Fetal Anomalies
FAR
Characteristics of Pregnancies Complicated by Fetal Anomalies
1 other identifier
observational
500
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 6, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
December 9, 2024
December 1, 2024
12 years
July 6, 2015
December 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Non-pregnant females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Tennesseelead
- Regional One Healthcollaborator
Study Sites (5)
LeBonheur Children's Hospital
Memphis, Tennessee, 38103, United States
Methodist LeBonheur Healthcare, LeBonheur Fetal Center
Memphis, Tennessee, 38103, United States
Regional One Health, OB/GYN Clinic, Maternal Fetal Medicine
Memphis, Tennessee, 38103, United States
Regional One Health, Regional Medical Center, Rout Center for Women and Children
Memphis, Tennessee, 38103, United States
Regional One Health Center for High Risk Pregnancies
Memphis, Tennessee, 38120, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norman Meyer, M.D.
Vice-Chair and Professor, MFM Fellowship Director Obstetrics and Gynecology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2015
First Posted
July 22, 2015
Study Start
May 1, 2015
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
December 9, 2024
Record last verified: 2024-12