Status:

ACTIVE_NOT_RECRUITING

Maternal-fetal Immune Responses to Fetal Surgery

Lead Sponsor:

Mayo Clinic

Conditions:

Spina Bifida

Congenital Diaphragmatic Hernia

Eligibility:

FEMALE

18-50 years

Brief Summary

Performing surgery in utero on fetuses with certain birth defects has led to significant improvements in outcomes after birth; however, many of these infants are born preterm which can decrease the ef...

Detailed Description

Over 300,000 neonates worldwide die in their first month of life due to a congenital birth defect. Thanks to advancements in diagnostic technology and imaging, the field of fetal surgery was developed...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for study group:
  • Maternal age ≥18 years
  • Pregnant with a congenital anomaly diagnosis AND undergoing fetal intervention in utero
  • Delivery planned at Mayo Clinic, Rochester MN
  • Inclusion Criteria for control group:
  • Maternal age ≥18 years
  • Pregnant with normal ultrasound findings
  • Delivery planned at Mayo Clinic, Rochester MN
  • Exclusion Criteria:
  • Delivery planned elsewhere
  • Abnormal fetal karyotype

Exclusion

    Key Trial Info

    Start Date :

    March 24 2022

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 30 2025

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT04484441

    Start Date

    March 24 2022

    End Date

    December 30 2025

    Last Update

    August 14 2025

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota, United States, 55905

    2

    Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, United States, 45229

    3

    University of Texas Houston

    Houston, Texas, United States, 77030