Amnioinfusion for Fetal Renal Failure
Fetal Care Center, PLLC · with Medical City Children's Hospital, Medical City Women's Hospital · NCT06728228
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Any age listed · Women only
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 35
- US sites recruiting
- 1
- Study start
- December 5, 2024
- Record last updated
- December 20, 2024
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Amnioinfusion
Conditions: Multicystic Dysplastic Kidney; Polycystic Kidney Disease; Fetal Renal Anomaly; Anhydramnios; Potter Syndrome; Lung Hypoplasia; Multicystic Renal Dysplasia, Bilateral; Lower Urinary Tract Obstructive Syndrome; Bilateral Renal Agenesis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Evidence of rupture of membranes or chorionic-amniotic separation.
- Evidence of preterm labor.
- Multiple gestation.
- Severe maternal medical condition in pregnancy.
- Clinically diagnosed maternal depression, psychoses, or anxiety that are refractory to treatment.
- Technical limitations precluding amnioinfusion.
Recruiting US locations
Fetal Care Center
Dallas, TX 75230
Site contact: Kevin P Magee, M.D. · (972) 566-5600 · kevin.magee@fetalcaredallas.com
Study contacts (from the official record)
- Kevin P Magee, M.D. · (972) 566-5600 · kevin.magee@fetalcaredallas.com