Maternal-fetal Immune Responses to Fetal Surgery

NCT04484441 | Completed

• 1 other identifier: 19-011382
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 3

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 effectiveness of these procedures. The investigators aim to understand the effects of surgery on the maternal and fetal immune system and whether immune activation may be causing some of these infants to be born prematurely.

Conditions

Lower Urinary Tract Obstructive Syndrome; Myelomeningocele; Spina Bifida; Congenital Diaphragmatic Hernia

Keywords

Fetal Surgery; Fetal Intervention; In Utero Surgery; In Utero Intervention

Outcome Measures

Primary Outcomes (1)

• Maternal T cell activation following in utero intervention.

  T cells from maternal blood will be isolated and CDR3 spectra typing will be completed. These samples will be compared to each other to identify high frequency T cell clones as well as longitudinal changes in the dynamics of clones. Blood collected at the four time points above will be profiled for changes in immune activation using mass cytometry (CyTOF) and plasma collected to measure changes in cytokine responses pre- and post-surgery by multiplex.

  Baseline, 1-2 days post intervention, 1 week post intervention, delivery

Secondary Outcomes (1)

• Placental histology in the maternal-fetal interface in term and preterm fetal intervention cases

  Delivery

Study Arms (2)

Fetal surgical intervention group

Pregnant adult women carrying a fetus with a diagnosed congenital anomaly and scheduled to undergo fetal surgical intervention at Mayo Clinic.

Other: Blood and placenta specimen collection.

Control group - normal pregnancy

Pregnant adult women with normal ultrasound findings. These women will be matched with the subjects enrolled in the intervention cohort for parity, maternal age, ethnicity, fetal sex and gestational age at time of surgical intervention.

Other: Blood and placenta specimen collection.

Interventions

Blood and placenta specimen collection. OTHER

Collection of maternal and paternal blood. Collection of infant cord blood and placenta.

Control group - normal pregnancy; Fetal surgical intervention group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will compare two groups of pregnant women. Each group will be comprised of maternal, paternal, fetal trios. The study cohort will be comprised of adult women carrying a fetus with a diagnosed congenital anomaly and scheduled to undergo fetal surgical intervention. The control cohort will enroll pregnant women with normal ultrasound findings that will be matched with the subjects enrolled in the study cohort for parity, maternal age, ethnicity, fetal sex and gestational age at time of surgical intervention.

You may qualify if:

• Maternal age ≥18 years
• Pregnant with a congenital anomaly diagnosis AND undergoing fetal intervention in utero
• Delivery planned at Mayo Clinic, Rochester MN
• Maternal age ≥18 years
• Pregnant with normal ultrasound findings
• Delivery planned at Mayo Clinic, Rochester MN

You may not qualify if:

• Delivery planned elsewhere
• Abnormal fetal karyotype

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, 55905, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University of Texas Houston

Houston, Texas, 77030, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Spinal Dysraphism; Hernias, Diaphragmatic, Congenital; Meningomyelocele

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mauro Schenone, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: March 24, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 1, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)