Your session is about to expire
← Back to Search
Procedure
Amnioinfusion for Fetal Kidney Anomalies
N/A
Recruiting
Research Sponsored by Fetal Care Center, PLLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up >=2 years after delivery.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if giving regular amnioinfusions to fetuses with severe kidney problems can improve their chances of survival. The study will also investigate if this procedure helps the fetus survive until dial
Who is the study for?
This trial is for pregnant individuals whose fetuses have severe kidney issues leading to low amniotic fluid, which can impact lung development. It's not specified who can't join the trial, but typically those with additional health risks or conditions that could interfere with the study may be excluded.
What is being tested?
The study tests whether adding fluid to the amniotic cavity (amnioinfusion) regularly can improve survival chances for fetuses with serious kidney problems until they're able to receive dialysis or a kidney transplant after birth.
What are the potential side effects?
While specific side effects are not listed, amnioinfusion procedures may carry risks such as infection, preterm labor, or harm to the fetus. Close monitoring during the trial aims to minimize these risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ >=2 years after delivery.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~>=2 years after delivery.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fetal Survival to Dialysis
Fetal Survival to Transplant
Incidence of Maternal Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
Mean gestational age at delivery in the intervention group
Mean gestational age at delivery in the non-intervention group
Mean gestational age at rupture of membranes in the intervention group
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AmnioinfusionExperimental Treatment1 Intervention
Those in this experimental arm, Amnioinfusion, will undergo serial amnioinfusion in addition to routine care as deemed appropriate by the study doctor.
Group II: Comfort Care/Expectant ManagementActive Control1 Intervention
The non-experimental arm, Comfort Care/Expectant Management, will undergo comfort care as elected by the participant.
Find a Location
Who is running the clinical trial?
Fetal Care Center, PLLCLead Sponsor
Medical City Children's HospitalOTHER
2 Previous Clinical Trials
27 Total Patients Enrolled
Medical City Women's HospitalUNKNOWN