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.
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.
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.
Parallel
Amnioinfusion
Other interventionA 20- or 22-gauge spinal needle (routinely used obstetrics and gynecology needle) will be used by an expert in fetal procedures with sterile technique to access the amniotic cavity under real-time ultrasound guidance to infuse isotonic fluid (Lactated Ringers with 1g/L of Oxacillin). This fluid will act as replacement amniotic fluid. Regular monitoring of fluid levels may suggest serial infusion, which will be completed as deemed necessary by the study doctor.
Fetal Survival to Dialysis
Proportion of neonates surviving to \>= 14 days and placement of dialysis access after serial amnioinfusions (defined as use of a dialysis catheter for \>=14 continuous days)
Fetal Survival to Transplant
The proportion of neonates who survive to receive a kidney transplant following continuous, successful dialysis.
Incidence of Maternal Treatment-Emergent Adverse Events [Safety and Tolerability]
Maternal safety will be assessed by tracking adverse events, including bleeding, infections, and preterm rupture of membranes, at each visit, after procedures, and postpartum. These events will be documented at each prenatal visit, following every amnioinfusion, at delivery, and during a follow-up period of at least 30 days postpartum. The safety evaluation will focus on identifying procedure-related complications and ensuring the well-being of participants throughout the study.
Number of infusions prior to rupture of membranes among participants in the intervention group
The practicality of performing serial amnioinfusions for early pregnancy renal anhydramnios will be evaluated by counting the number of infusions administered before rupture of membranes in the intervention group.
Mean gestational age at rupture of membranes in the intervention group
The feasibility of serial amnioinfusions will be assessed by determining the average gestational age at which rupture of membranes occurs in the intervention group.
Mean gestational age at delivery in the intervention group
The feasibility of serial amnioinfusions will be measured by calculating the mean gestational age at delivery among participants in the intervention group.
Rate of fetal demise in utero among participants in the non-intervention group
An exploratory analysis will examine the natural progression of untreated early pregnancy renal anhydramnios by analyzing the rate of in utero fetal demise in the non-intervention group.
Click on the lead sponsor to view all of their trials.
Fetal Care Center, PLLC
Lead sponsor
Medical City Children's Hospital
Collaborator
Medical City Women's Hospital
Collaborator
