Amnioinfusion for Fetal Renal Failure (NCT06728228) | Clinical Trial Compass
RecruitingNot Applicable
Amnioinfusion for Fetal Renal Failure
United States35 participantsStarted 2024-12-05
Plain-language 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 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.
Who can participate
SexFEMALE
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Inclusion criteria
✓. Confirmed anhydramnios before 22 weeks GA for patients with FRF.
✓. Consent is signed and first therapeutic amnioinfusion can and does occur before 28 weeks and 6/7 days GA.
✓. Confirmation that the expectant mother understands her options for management of the pregnancy.
✓. Age ≥18 years of age.
✓. Willingness to be followed by the Fetal Care Center at Dallas and deliver at Medical City Dallas.
✓. Willingness for postnatal care to be performed at Medical City Dallas Hospital/the Fetal Care Center until maternal discharge.
✓. Consults with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric surgery, Maternal-Fetal Medicine Specialist, and a Genetic Counselor.
Exclusion criteria
✕. Cervix less than 2.5 cm in length.
✕. 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).
✕. Other significant congenital anomalies in the fetus.
What they're measuring
1
Fetal Survival to Dialysis
Timeframe: Birth to either survival to >=14 days and placement of dialysis access, or nonsurvival, up to 3 weeks.
2
Fetal Survival to Transplant
Timeframe: >=2 years after delivery.
3
Incidence of Maternal Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: From enrollment in the study through delivery and up to 30 days postpartum.