IRB Study Number 23-1339
Status Recruiting
Location M Building - Cleveland Clinic Children's
Institute Obstetrics and Gynecology and Women's Health Institute
Description
This research is being done to find out if repeated infusions of replacement amniotic fluid into the womb can reliably rescue the lung function of fetuses that do not make urine, and as a result, there is no amniotic fluid. This condition occurs when the fetus has a severe birth defect called congenital bilateral renal agenesis (CoBRA) and/or fetal renal failure (FRF). We hope to discover whether this fetal intervention can make early pregnancy renal anhydramnios, called EPRA, reliably survivable after birth.
Inclusion Criteria
1) Confirmed anhydramnios before 22 weeks 0 days GA for patients with Fetal Renal Failure
2) Consent is signed and first therapeutic amnioinfusion can and does occur before 26 weeks and 0 days GA
3) Confirmation that the expectant mother does not wish to undergo termination of the pregnancy
4) Age ≥18 years for expectant mothers
5) Willingness to be followed and deliver at a RAFT center if in the intervention arm. Expectant management arm has the option to be followed and deliver at a local hospital/hospital other than a RAFT site, and allow medical records to be sent to the RAFT site.
6) Willingness for postnatal care to be performed at a RAFT center until discharge if in the intervention arm
7) Completed consults with pediatric nephrology, neonatology, transplant surgery, pediatric surgery, maternal-fetal medicine, a licensed clinical social worker, and a genetic counselor
Exclusion Criteria
1) Cervix less than 2.5 cm in length
2) Any significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray
3) Other clinically relevant congenital anomalies in the fetus
4) Autosomal recessive polycystic kidney disease in the fetus
5) Evidence of chorioamnionitis or abruptio placentae
6) Evidence of rupture of membranes or clinically relevant chorioamniotic separation
7) Clinically relevant evidence of preterm labor
8) Multiple gestation
9) Severe maternal medical condition in pregnancy
10) Maternal depression, as assessed by a Beck Depression Inventory score ≥17, that is refractory to treatment
11) Technical limitations precluding amnioinfusion
