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NCT04484441 · ClinicalTrials.gov registry record
Maternal-fetal Immune Responses to Fetal Surgery
A clinical trial, sponsored by Mayo Clinic.
- Completed
- Registry status
- 21
- Enrollment target
NCT04484441: Completed study, sponsored by Mayo Clinic.
NCT04484441 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04484441 has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 21 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Blood and placenta specimen collection.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2022-03-24 |
| Est. Completion | 2025-12-01 |
What the finished NCT04484441 record still lists
NCT04484441 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 21 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Blood and placenta specimen collection. is the first listed.
NCT04484441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04484441 about?
NCT04484441 is a clinical study titled "Maternal-fetal Immune Responses to Fetal Surgery". 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 m...
What is the current status of trial NCT04484441?
This trial is currently completed. The enrollment target is 21 participants. The study started on 2022-03-24. Estimated completion is 2025-12-01.
What interventions are being tested in trial NCT04484441?
The interventions under investigation include: Blood and placenta specimen collection. (OTHER).
Who is sponsoring clinical trial NCT04484441?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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