Renal Anhydramnios Fetal Therapy

• Status: Recruiting
• Trial end date: 2030-03-18
• Target enrollment: 0
• Participant gender: Female

Summary

Early pregnancy renal anhydramnios or EPRA is a condition where a pregnant woman does not have any amniotic fluid around her fetus because of a problem with the fetus's kidneys. This condition is thought to be fatal once the fetus is born because of inadequate lung growth. The Renal Anhydramnios Fetal Therapy (RAFT) Trial offers eligible pregnant women with a diagnosis of EPRA an experimental therapy of repeated or serial "amnioinfusions" of fluid into the womb. An amnioinfusion involves placing a small needle through the pregnant woman's skin into the womb next to the fetus. Warm sterile fluid with balanced electrolytes and antibiotics is then slowly infused into amniotic space inside the womb. The aim is to help the fetus's lungs grow enough so he or she can survive after birth. These amnioinfusions will be carried out by an expert in fetal interventions at a RAFT center. There is a significant risk of early rupture of membranes and early delivery in subjects who receive amnioinfusions, and any potential trial participants will be counseled about these risks before they decide whether to join the trial. Any eligible patients who, after counseling, elect to terminate the pregnancy will not be eligible to participate in the trial. All eligible patients who choose to join the RAFT trial will be able to choose their assignment into one of two arms of the study: (1) to receive serial amnioinfusions (2) to not receive amnioinfusions but receive monitoring for the remainder of the pregnancy at the RAFT center. Thus, assignment of patients to study arm will not be random, but will be decided by the participant. Fetuses who do survive after birth will require intensive medical management for kidney failure including placement of a dialysis catheter and dialysis therapy with the eventual need for a kidney transplant. Treatment for lung disease secondary to abnormal lung development may also be required. The study will follow babies and their families until non-survival or transplant.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University

Criteria

Inclusion Criteria:

1. Confirmed anhydramnios before 22 weeks GA for patients with FRF or confirmed diagnosis of CoBRA

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 of age for expectant mothers

5. Willingness to be followed and deliver at a RAFT center

6. Willingness for postnatal care to be performed at a RAFT center until discharge

7. 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:

1. Cervix less than 2.5 cm in length

2. No significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray

3. Other significant congenital anomalies in the fetus

4. Evidence of chorioamnionitis or abruptio placentae

5. Evidence of rupture of membranes or chorioamniotic separation

6. Evidence of preterm labor

7. Multiple gestation

8. Severe maternal medical condition in pregnancy.

9. Maternal depression as assessed by a Beck Depression Inventory score equal to or greater than 17 that is refractory to treatment

10. Technical limitations precluding amnioinfusion