NCT04484441|Completed
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Sponsor study identifier
observational
21
1 country
3
Study Start
March 24, 2022
Actual (reported)Primary Completion
December 31, 2024
Actual (reported)Study Completion
December 1, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2020
Actual (reported)July 23, 2020
Actual (reported)March 24, 2022
Actual (reported)December 31, 2024
Actual (reported)December 1, 2025
Actual (reported)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
Placental histology in the maternal-fetal interface in term and preterm fetal intervention cases
Delivery
Pregnant adult women carrying a fetus with a diagnosed congenital anomaly and scheduled to undergo fetal surgical intervention at Mayo Clinic.
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.
Collection of maternal and paternal blood. Collection of infant cord blood and placenta.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University of Texas Houston
Houston, Texas, 77030, United States
Mauro Schenone, MD
Mayo Clinic
21 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2020
First Posted
July 23, 2020
Study Start
March 24, 2022
Actual (reported)Automated Myocardial Performance Index Using Samsung HERA W10
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2024
Actual (reported)Study Completion
December 1, 2025
Actual (reported)Last Updated
February 10, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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