Amnioinfusion for Fetal Renal Failure

Description

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

Multicystic Dysplastic Kidney, Polycystic Kidney Disease, Fetal Renal Anomaly, Anhydramnios, Potter Syndrome, Lung Hypoplasia, Multicystic Renal Dysplasia, Bilateral, Lower Urinary Tract Obstructive Syndrome, Bilateral Renal Agenesis

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Study Overview

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Study Details

Study overview

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.

Amnioinfusion for Fetal Renal Failure

Amnioinfusion for Fetal Renal Failure

Condition
Multicystic Dysplastic Kidney
Intervention / Treatment

-

Contacts and Locations

Dallas

Fetal Care Center, Dallas, Texas, United States, 75230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Confirmed anhydramnios before 22 weeks GA for patients with FRF.
  • 2. Consent is signed and first therapeutic amnioinfusion can and does occur before 28 weeks and 6/7 days GA.
  • 3. Confirmation that the expectant mother understands her options for management of the pregnancy.
  • 4. Age ≥18 years of age.
  • 5. Willingness to be followed by the Fetal Care Center at Dallas and deliver at Medical City Dallas.
  • 6. Willingness for postnatal care to be performed at Medical City Dallas Hospital/the Fetal Care Center until maternal discharge.
  • 7. Consults with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric surgery, Maternal-Fetal Medicine Specialist, and a Genetic Counselor.
  • 1. Cervix less than 2.5 cm in length.
  • 2. No fatal findings on Karyotype (e.g trisomy 13, or 18) or Microarray fatal findings excluding those that are related to pulmonary hypoplasia due to fetal renal failure (e.g. Meckel-Gruber, PCKD).
  • 3. Other significant congenital anomalies in the fetus.
  • 4. Evidence of chorioamnionitis or abruptio placentae.
  • 5. Evidence of rupture of membranes or chorionic-amniotic separation.
  • 6. Evidence of preterm labor.
  • 7. Multiple gestation.
  • 8. Severe maternal medical condition in pregnancy.
  • 9. Clinically diagnosed maternal depression, psychoses, or anxiety that are refractory to treatment.
  • 10. Technical limitations precluding amnioinfusion.

Ages Eligible for Study

to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Fetal Care Center, PLLC,

Study Record Dates

2026-11-15