Amnioinfusion for Fetal Renal Failure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorFetal Care Center, PLLC

About this trial

The goal of this clinical trial is to learn if serial amnioinfusions can improve the chances of survival for fetuses with severe kidney problems that cause low amniotic fluid (anhydramnios). Low amniotic fluid can affect lung development and may lead to serious health issues for the fetus. The main questions this study aims to answer are:

* Can serial amnioinfusion increase the chances of survival for these fetuses? * Does this procedure improve chances of survival until dialysis and/or kidney transplant?

Participants will:

* Receive regular amnioinfusions, which is a procedure that adds fluid to the amniotic cavity. * Undergo monitoring to check the effects on the fetus and mother.

This study will help researchers understand if amnioinfusion is a useful treatment for fetal kidney problems and may provide valuable information for similar cases in the future.

Eligibility criteria

Qualifiers

Confirmed anhydramnios before 22 weeks GA for patients with FRF.

Consent is signed and first therapeutic amnioinfusion can and does occur before 28 weeks and 6/7 days GA.

Confirmation that the expectant mother understands her options for management of the pregnancy.

Age ≥18 years of age.

Disqualifiers

Cervix less than 2.5 cm in length.

No fatal findings on Karyotype (e.g trisomy 13, or 18) or Microarray fatal findings excluding those that are related to pulmonary hypoplasia due to fetal renal failure (e.g. Meckel-Gruber, PCKD).

Other significant congenital anomalies in the fetus.

Evidence of chorioamnionitis or abruptio placentae.

Trial design

Treatments tested in this trial

  • Amnioinfusion

Treatment groups

35 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fetal Care Center, PLLC

Lead sponsor

Medical City Children's Hospital

Collaborator

Medical City Women's Hospital

Collaborator