Actively Recruiting

Phase Not Applicable
FEMALE
NCT06728228

Amnioinfusion for Fetal Renal Failure

Led by Fetal Care Center, PLLC · Updated on 2024-12-20

35

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

Sponsors

F

Fetal Care Center, PLLC

Lead Sponsor

M

Medical City Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if serial amnioinfusions can improve the chances of survival for fetuses with severe kidney problems that cause low amniotic fluid (anhydramnios). Low amniotic fluid can affect lung development and may lead to serious health issues for the fetus. The main questions this study aims to answer are: * Can serial amnioinfusion increase the chances of survival for these fetuses? * Does this procedure improve chances of survival until dialysis and/or kidney transplant? Participants will: * Receive regular amnioinfusions, which is a procedure that adds fluid to the amniotic cavity. * Undergo monitoring to check the effects on the fetus and mother. This study will help researchers understand if amnioinfusion is a useful treatment for fetal kidney problems and may provide valuable information for similar cases in the future.

CONDITIONS

Official Title

Amnioinfusion for Fetal Renal Failure

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed anhydramnios before 22 weeks of gestation for fetal renal failure
  • Signed consent and first amnioinfusion before 28 weeks and 6 days of gestation
  • Expectant mother understands pregnancy management options
  • 18 years of age or older
  • Willing to be followed and deliver at the Fetal Care Center at Dallas and Medical City Dallas
  • Agree to postnatal care at Medical City Dallas Hospital/Fetal Care Center until discharge
  • Consultations with pediatric nephrology, neonatology, transplant surgery, pediatric surgery, maternal-fetal medicine, and genetic counseling
Not Eligible

You will not qualify if you...

  • Cervix shorter than 2.5 cm
  • Fatal genetic findings unrelated to pulmonary hypoplasia due to fetal renal failure
  • Other significant fetal congenital anomalies
  • Signs of infection (chorioamnionitis) or placental abruption
  • Ruptured membranes or separation between chorion and amnion
  • Signs of preterm labor
  • Multiple pregnancies
  • Severe maternal medical conditions during pregnancy
  • Untreated or treatment-resistant maternal depression, psychosis, or anxiety
  • Technical reasons preventing safe amnioinfusion

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Fetal Care Center

Dallas, Texas, United States, 75230

Actively Recruiting

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Research Team

K

Kevin P Magee, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Amnioinfusion for Fetal Renal Failure | DecenTrialz