35 Participants Needed

Amnioinfusion for Fetal Kidney Anomalies

KP
Overseen ByKevin P Magee, M.D.
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: Fetal Care Center, PLLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Amnioinfusion for Fetal Kidney Anomalies?

Amnioinfusion has shown success in promoting lung growth and survival in fetuses with early pregnancy renal anhydramnios (EPRA), with some surviving the neonatal period and receiving kidney transplants. Additionally, amnioinfusion has been beneficial in reducing complications during labor in cases of oligohydramnios, such as decreasing the need for cesarean sections and improving fetal outcomes.12345

Is amnioinfusion generally safe for humans?

Amnioinfusion is generally considered safe with few adverse effects, although there are some reports of complications like amniotic fluid embolism. Studies show it can reduce certain risks during labor, but more research is needed on potential maternal adverse events.13678

How is the treatment Amnioinfusion unique for fetal kidney anomalies?

Amnioinfusion is unique because it involves injecting fluid into the amniotic sac to improve ultrasound visibility, which helps diagnose and manage fetal kidney anomalies. Unlike other treatments, it can be used to enhance visualization of fetal structures and potentially improve outcomes in cases of severe oligohydramnios (low amniotic fluid) and kidney issues.29101112

What is the purpose of this trial?

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 Criteria

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.

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.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group receive serial amnioinfusions to improve fetal survival and lung development

Up to 9 months
Regular visits for amnioinfusion procedures and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including maternal safety and fetal survival outcomes

Up to 30 days postpartum
Visits at delivery and during postpartum period

Long-term Follow-up

Monitoring of fetal survival to dialysis and potential kidney transplant eligibility

Up to 2 years after delivery

Treatment Details

Interventions

  • Amnioinfusion
Trial Overview 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.
Participant Groups
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.

Amnioinfusion is already approved in United States for the following indications:

🇺🇸
Approved in United States as Amnioinfusion for:
  • Prophylactic treatment of oligohydramnios
  • Reduction of variable decelerations of the fetal heart rate due to cord compression during labor
  • Treatment of preterm premature rupture of membranes at 26 weeks' gestation or later

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fetal Care Center, PLLC

Lead Sponsor

Trials
1
Recruited
40+

Medical City Children's Hospital

Collaborator

Trials
3
Recruited
60+

Medical City Women's Hospital

Collaborator

Trials
1
Recruited
40+

Findings from Research

Amnioinfusions have shown promise in treating early pregnancy renal anhydramnios (EPRA), with some fetuses surviving the neonatal period and successfully undergoing dialysis and kidney transplants, suggesting potential for improved outcomes.
There are currently no reports of untreated EPRA survivors, highlighting the critical need for rigorous prospective trials to evaluate the efficacy of amnioinfusions and other fetal therapies for this condition.
Amnioinfusions to Treat Early Onset Anhydramnios Caused by Renal Anomalies: Background and Rationale for the Renal Anhydramnios Fetal Therapy Trial.O'Hare, EM., Jelin, AC., Miller, JL., et al.[2021]
A case of bilateral renal agenesis was successfully managed with serial amnioinfusion, which helped improve fetal lung development and allowed the newborn to survive the critical newborn period.
The newborn, now 9 months old, is undergoing peritoneal dialysis as a bridge to planned renal transplantation, demonstrating the potential of amnioinfusion in enhancing outcomes for similar cases.
Successful in utero intervention for bilateral renal agenesis.Bienstock, JL., Birsner, ML., Coleman, F., et al.[2021]
In a study of 305 patients with oligohydramnios, prophylactic amnioinfusion significantly reduced the need for operative interventions due to fetal distress and lowered the cesarean section rate, indicating its efficacy in improving labor outcomes.
Patients who received amnioinfusion also had higher umbilical artery pH levels at delivery and shorter hospital stays, suggesting that this intervention can enhance fetal well-being without increasing the risk of complications like amnionitis or endometritis.
Prophylactic amnioinfusion as a treatment for oligohydramnios in laboring patients: a prospective, randomized trial.Schrimmer, DB., Macri, CJ., Paul, RH.[2019]

References

Amnioinfusions to Treat Early Onset Anhydramnios Caused by Renal Anomalies: Background and Rationale for the Renal Anhydramnios Fetal Therapy Trial. [2021]
Successful in utero intervention for bilateral renal agenesis. [2021]
Prophylactic amnioinfusion as a treatment for oligohydramnios in laboring patients: a prospective, randomized trial. [2019]
Two infants with bilateral renal agenesis who were bridged by chronic peritoneal dialysis to kidney transplantation. [2021]
Clinical role of amnio-infusion. [2019]
Amniotic fluid embolism after saline amnioinfusion: two cases and review of the literature. [2015]
Transabdominal amnioinfusion: An evaluation of its adverse events. [2022]
Amnioinfusion survey: prevalence, protocols, and complications. [2019]
Diagnostic transabdominal amnioinfusion in a case of anhydramnion and fetal kidney dysplasia. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Amnioinfusion: an aid in the ultrasonographic evaluation of severe oligohydramnios in pregnancy. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Diagnostic and therapeutic transabdominal amnioinfusion in oligohydramnios. [2016]
Visualization of fetal intra-abdominal organs in second-trimester severe oligohydramnios by intraperitoneal infusion. [2019]
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