Spina Bifida Clinical Trial
Official title:
Maternal-fetal Immune Responses to Fetal Surgery
Verified date | February 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | University of Texas Houston | Houston | Texas |
United States | Mayo Clinic in Rochester, Minnesota | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Placental histology in the maternal-fetal interface in term and preterm fetal intervention cases | Placental macrophages will be phenotyped for subtypes (M1 classical versus M2 repair), activation (CD25 and CD40), and apoptosis status by CyTOF. Comparisons will be made between those born before 37 weeks and those born after 37 weeks in the surgical group, as well as to those who didn't undergo surgery.
From each placenta, 5 sections will be dissected and submitted for histological evaluation of placental villitis. Toxoplasmosis, Other [syphilis, varicella-zoster, parvovirus B19], Rubella, Cytomegalovirus and Herpes (TORCH) infection panels will be completed to distinguish infectious villitis from immune-mediated villitis. |
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