Renal Anhydramnios Fetal Therapy (RAFT)
Anhydramnios, Potter Syndrome, Lung Hypoplasia
About this trial
This is an interventional treatment trial for Anhydramnios focused on measuring Amnioinfusion, Fetal therapy, Bilateral Renal Agenesis, Fetal Renal Failure, Lower Urinary Tract Obstruction (LUTO), Anhydramnios
Eligibility Criteria
Inclusion Criteria:
- Confirmed anhydramnios before 22 weeks GA for patients with fetal renal failure (excluding bilateral renal agenesis)
- Consent is signed and first therapeutic amnioinfusion can and does occur before 26 weeks and 0 days GA
- Confirmation that the expectant mother does not wish to undergo termination of the pregnancy
- Age ≥ 18 years of age for expectant mothers
- Willingness to be followed and deliver at a RAFT center
- Willingness for postnatal care to be performed at a RAFT center until discharge
- Completed consults with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric surgery, Maternal-Fetal Medicine Specialist, and Licensed Clinical Social Worker and a Genetic Counselor
Exclusion Criteria:
- Cervix less than 2.5 cm in length
- No significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray
- Other significant congenital anomalies in the fetus
- Evidence of chorioamnionitis or abruptio placentae
- Evidence of rupture of membranes or chorioamniotic separation
- Evidence of preterm labor
- Multiple gestation
- Severe maternal medical condition in pregnancy.
- Maternal depression as assessed by a Beck Depression Inventory score equal to or greater than 17 that is refractory to treatment
- Technical limitations precluding amnioinfusion
Sites / Locations
- University of Southern California/Children's Hospital of Los Angeles/Huntington HospitalRecruiting
- University of California San FranciscoRecruiting
- Stanford UniversityRecruiting
- University of Colorado DenverRecruiting
- Johns Hopkins HospitalRecruiting
- Mayo ClinicRecruiting
- Columbia UniversityRecruiting
- Children's Hospital of PhiladelphiaRecruiting
- University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Serial amnioinfusions with isotonic fluid
Expectant
There are two interventional arms to the trial. Recruitment in the bilateral renal agenesis arm of the trial was stopped in July 2022 after DSMB review. Recruitment is ongoing in the non-bilateral renal agenesis, fetal renal failure with anhydramnios arm of the trial. Patients will undergo amnioinfusions with isotonic fluid every 2-12 days.. A spinal needle will be used to perform the infusion. The latest infusions will begin is 26 weeks gestation. Standard postnatal care will occur at a RAFT center.
Patients will be observed serially by ultrasound, fetal echocardiogram and MRI. Standard postnatal care will occur at a RAFT center.