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Fetal surgery immune mystery: why do some babies arrive too early?

NCT ID NCT04484441

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 21 pregnant women and their babies to understand how surgery before birth changes the immune system. The goal was to find out if immune system activation might cause early labor. Researchers collected blood samples and studied the placenta to track immune changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

21 people

The number who actually took part.

Started

Mar 2022

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

congenital diaphragmatic hernia lower urinary tract obstruction, congenital myelomeningocele spina bifida urinary tract obstruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital diaphragmatic hernia Lower urinary tract obstructive syndrome Myelomeningocele Spina bifida

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota, 55905, United States

  • University of Texas Houston

    Houston, Texas, 77030, United States

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