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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.Fetal renal failure (FRF) is a severe and life-threatening condition caused by congenital abnormalities or inherited kidney di

Trial Eligibility

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.

Study Info

Organization

Fetal Care Center, PLLC


Primary Outcome

Fetal Survival to Dialysis


Outcome Timeframe Birth to either survival to >=14 days and placement of dialysis access, or nonsurvival, up to 3 weeks.

NCTID NCT06728228

Phases NA

Primary Purpose TREATMENT

Start Date 2024-12-05

Completion Date 2025-11-15

Enrollment Target 35

Interventions

OTHER Amnioinfusion

Locations Recruiting

Fetal Care Center

United States, Texas, Dallas


Interested in joining this trial?

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