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
Sponsors and collaborators
Fetal Care Center, PLLC
Lead sponsor
Medical City Children's Hospital
Collaborator
Medical City Women's Hospital
Collaborator