Status:

RECRUITING

Amnioinfusion for Fetal Renal Failure

Lead Sponsor:

Fetal Care Center, PLLC

Collaborating Sponsors:

Medical City Children's Hospital

Medical City Women's Hospital

Conditions:

Multicystic Dysplastic Kidney

Polycystic Kidney Disease

Eligibility:

FEMALE

Phase:

NA

Brief Summary

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 amnio...

Detailed Description

Fetal renal failure (FRF) is a severe and life-threatening condition caused by congenital abnormalities or inherited kidney diseases. In the womb, when the kidneys fail to function properly, this lead...

Eligibility Criteria

Inclusion 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.

Exclusion criteria:

  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.

Key Trial Info

Start Date :

December 5 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 15 2026

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT06728228

Start Date

December 5 2024

End Date

November 15 2026

Last Update

December 20 2024

Active Locations (1)

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1

Fetal Care Center

Dallas, Texas, United States, 75230