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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Mauro Schenone, M.D.

Abierto para la inscripción

Contact information:

Maureen Lemens C.C.R.C.

(507) 293-1487

Lemens.Maureen@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20523808

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