Pregnancies Complicated by Fetal Anomalies

NCT ID: NCT02505464

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2028-04-30

Brief Summary

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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

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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.

Conditions

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Pregnancy Congenital Abnormalities

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

1 Minute

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regional One Health

OTHER

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Norman Meyer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vice-Chair and Professor, MFM Fellowship Director Obstetrics and Gynecology

Locations

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LeBonheur Children's Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

Methodist LeBonheur Healthcare, LeBonheur Fetal Center

Memphis, Tennessee, United States

Site Status RECRUITING

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

Memphis, Tennessee, United States

Site Status RECRUITING

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

Memphis, Tennessee, United States

Site Status RECRUITING

Regional One Health Center for High Risk Pregnancies

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Norman Meyer, M.D.

Role: CONTACT

Phone: 901-448-2531

Email: [email protected]

Annette B. Hickerson, R.N., CCRC

Role: CONTACT

Phone: 901-448-4784

Email: [email protected]

Facility Contacts

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Annette B. Hickerson, RN, CCRC

Role: primary

Annette B. Hickerson, RN, CCRC

Role: primary

Annette B. Hickerson, R.N.

Role: primary

Annette B. Hickerson, RN, CCRc

Role: primary

Annette B. Hickerson, R.N.

Role: primary

Other Identifiers

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15-03804-XP

Identifier Type: -

Identifier Source: org_study_id