Recruiting

Amnioinfusion

Sponsor:

Fetal Care Center, PLLC

Code:

NCT06728228

Conditions

Multicystic Dysplastic Kidney

Polycystic Kidney Disease

Fetal Renal Anomaly

Anhydramnios

Potter Syndrome

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Amnioinfusion

Study Details

Brief 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.

Conditions

Multicystic Dysplastic Kidney

Polycystic Kidney Disease

Fetal Renal Anomaly

Anhydramnios

Potter Syndrome

Study ID

NCT06728228

Start date

Dec 5, 2024

Status verified date

Dec, 2024

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Nov 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion criteria:

1. Confirmed anhydramnios before 22 weeks GA for patients with FRF.
2. Consent is signed and first therapeutic amnioinfusion can and does occur before 28 weeks and 6/7 days GA.
3. Confirmation that the expectant mother understands her options for management of the pregnancy.
4. Age ≥18 years of age.
5. Willingness to be followed by the Fetal Care Center at Dallas and deliver at Medical City Dallas.
6. Willingness for postnatal care to be performed at Medical City Dallas Hospital/the Fetal Care Center until maternal discharge.
7. Consults with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric surgery, Maternal-Fetal Medicine Specialist, and a Genetic Counselor.

Exclusion criteria:

1. Cervix less than 2.5 cm in length.
2. 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).
3. Other significant congenital anomalies in the fetus.
4. Evidence of chorioamnionitis or abruptio placentae.
5. Evidence of rupture of membranes or chorionic-amniotic separation.
6. Evidence of preterm labor.
7. Multiple gestation.
8. Severe maternal medical condition in pregnancy.
9. Clinically diagnosed maternal depression, psychoses, or anxiety that are refractory to treatment.
10. Technical limitations precluding amnioinfusion.

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Amnioinfusion

A 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.

Primary outcome measure

  • Fetal Survival to Dialysis [ Time Frame: Birth to either survival to >=14 days and placement of dialysis access, or nonsurvival, up to 3 weeks. ]
  • Fetal Survival to Transplant [ Time Frame: >=2 years after delivery. ]
  • Incidence of Maternal Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: From enrollment in the study through delivery and up to 30 days postpartum. ]

Central Contacts and Locations

Central contacts

Kevin P Magee, M.D.

(972) 566-5600kevin.magee@fetalcaredallas.com

Locations

Fetal Care Center

Recruiting

Dallas, Texas, United States, 75230

Contacts

Kevin P Magee, M.D.

(972) 566-5600kevin.magee@fetalcaredallas.com

More Information

Sponsor

Fetal Care Center, PLLC

Last update posted

Dec 20, 2024

Last verified

Dec, 2024

Keywords

  • Fetal Renal Failure
  • Kidney Disease
  • MCDK
  • PCKD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fetal Care Center, PLLC on 2024-12-20.