Amnioinfusion to help fetuses with kidney problems

Amnioinfusion for Fetal Renal Failure

This study is testing if giving extra fluid to pregnant women with fetuses that have serious kidney problems can help improve the babies' chances of survival and healthy development.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sex: Female
• Sponsor: Fetal Care Center, PLLC (Industry-sponsored)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT06728228 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine if serial amnioinfusions can enhance survival rates for fetuses suffering from severe kidney issues that lead to low amniotic fluid, known as anhydramnios. The procedure involves injecting sterile fluid into the amniotic cavity to restore fluid levels, which is crucial for fetal lung development. Participants will receive regular amnioinfusions and undergo monitoring to assess the effects on both the fetus and the mother. The study seeks to build on previous findings that suggest this intervention may improve neonatal outcomes for affected families.

Who should consider this trial

Good fit: Ideal candidates are pregnant individuals with confirmed anhydramnios due to fetal renal failure before 22 weeks of gestation.

Not a fit: Patients with significant congenital anomalies or those with a cervix shorter than 2.5 cm may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly increase the chances of survival for fetuses with severe kidney problems.

How similar studies have performed: Previous studies, such as the RAFT trial, have shown promising results with similar approaches, indicating potential for success.

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.

Where this trial is running

Dallas, Texas

• Fetal Care Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Kevin P Magee, M.D.

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