A Study to Analyze the Renal Anhydramnios Fetal Therapy (RAFT)

Overview

About this study

This study aims to determine the proportion of neonates surviving to successful dialysis after serial amnioinfusions (defined as use of a dialysis catheter for > 15 continuous days) and to determine the feasibility of serial amnioinfusions for early pregnancy renal anhydramnios (EPRA). It also aims to perform an exploratory study of the in utero natural history of untreated EPRA and to examine correlations between prenatal ultrasound, echocardiogram, MRI, and lung specific factors in amniotic fluid as predictive biomarkers of the success of RAFT for EPRA. Lastly, the study aims to determine the short term and long-term quality of life of patients and families that undergo RAFT.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Confirmed anhydramnios before 22 weeks GA for patients with FRF or confirmed diagnosis of CoBRA.
    • Anhydramnios in the absence of ruptured membranes (ROM) on ultrasound.
    • No significant bladder filling on ultrasound.
  • Consent is signed and first therapeutic amnioinfusion can and does occur before 26 weeks and 0 days gestational age.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mauro Schenone, M.D.

Open for enrollment

Contact information:

Maureen Lemens R.N.

(507) 293-1487

Lemens.Maureen@mayo.edu

More information

Publications

Publications are currently not available