Serial Amnioinfusions for Severe Fetal Urinary Conditions

Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia

Recruiting Phase 1 Interventional Study
Renal Failure Congenital Congenital Renal Anomaly Nos Renal Agenesis and Dysgenesis Lower Urinary Tract Obstructive Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for

This trial is looking for pregnant women with certain severe conditions in their babies, like serious kidney issues or bladder problems. If you qualify, you may receive a treatment to help improve your baby's lung function and increase their chances of survival.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am pregnant with a single baby
  • I am over 18 years old
  • My baby is less than 26 weeks old and has severe urinary obstruction
  • My baby is less than 26 weeks old and has no kidneys formed
  • My baby does not have chromosome abnormalities
  • My baby does not have other birth defects
  • I do not have Hepatitis B, Hepatitis C, or HIV
  • I can make decisions about my baby

You may not be able to join if

  • My baby has other unrelated birth defects
  • I am at high risk for early labor
  • There are known issues with my placenta
  • I have conditions that make surgery unsafe
  • I have declined invasive tests for my baby
  • I cannot meet the travel and follow-up requirements
  • I am involved in another study that affects my pregnancy
  • I have participated in this trial before

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial
Congenital lower urinary tract obstruction (LUTO) is a heterogeneous group of congenital anomalies that lead bladder outlet obstruction. If a complete obstruction is present, the perinatal mortality is estimated to be as high as 90% because of severe pulmonary hypoplasia due to the lack of amniotic fluid. Survivors have significant risk of renal impairment (90%) requiring dialysis or renal transpl…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Pregnant women with singleton uterine pregnancy * Maternal age \> age 18 * Fetus \< 26 weeks gestational age with severe LUTO and intrauterine renal failure * Fetus \< 26 weeks gestational age with bilateral renal agenesis * Fetus with absence of chromosome abnormalities * Fet…
Contacts

Taylor M Rasmusson, MSN

507-266-4813

Rasmusson.Taylor@mayo.edu

CONTACT

Jainnee McCann

507-538-5679

McCann.Jainnee@mayo.edu

CONTACT