Amnioinfusion for Fetal Renal Failure

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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.

• Willingness to be followed by the Fetal Care Center at Dallas and deliver at Medical City Dallas.

• Willingness for postnatal care to be performed at Medical City Dallas Hospital/the Fetal Care Center until maternal discharge.

• Consults with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric surgery, Maternal-Fetal Medicine Specialist, and a Genetic Counselor.

Locations
United States
Texas
Fetal Care Center
RECRUITING
Dallas
Contact Information
Primary
Kevin P Magee, M.D.
kevin.magee@fetalcaredallas.com
(972) 566-5600
Time Frame
Start Date: 2024-12-05
Estimated Completion Date: 2026-11-15
Participants
Target number of participants: 35
Treatments
Experimental: Amnioinfusion
Those in this experimental arm, Amnioinfusion, will undergo serial amnioinfusion in addition to routine care as deemed appropriate by the study doctor.
No_intervention: Comfort Care/Expectant Management
The non-experimental arm, Comfort Care/Expectant Management, will undergo comfort care as elected by the participant.
Sponsors
Collaborators: Medical City Children's Hospital, Medical City Women's Hospital
Leads: Fetal Care Center, PLLC

This content was sourced from clinicaltrials.gov

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