Amnioinfusion for Fetal Kidney Anomalies

Overseen By Kevin P Magee, M.D.

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Fetal Care Center, PLLC

Disqualifiers: Cervix <2.5 cm, Trisomy 13/18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 9 months

35 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{2 9 10 11 12}

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.

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

Group I: Amnioinfusion Experimental Treatment 1 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 Management Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic amnioinfusion as a treatment for oligohydramnios in laboring patients: a prospective, randomized trial. Schrimmer, DB., Macri, CJ., Paul, RH.[2019]

This study presents two cases of infants diagnosed with bilateral renal agenesis who underwent prenatal amnioinfusions, a procedure that may help improve outcomes for affected fetuses, despite the historical challenges associated with this condition.

Both infants were managed with chronic peritoneal dialysis after birth, which served as a temporary solution until they could receive living related kidney transplants, marking a potential shift in the management of this previously fatal condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two infants with bilateral renal agenesis who were bridged by chronic peritoneal dialysis to kidney transplantation. Sheldon, CR., Kim, ED., Chandra, P., et al.[2021]

Amnio-infusion is a beneficial technique during pregnancy that can enhance fetal imaging and may help in administering antibiotics or preventing lung development issues.

Clinical trials indicate that intrapartum amnio-infusion significantly reduces the need for emergency cesarean sections due to fetal distress and complications from meconium, although more research is needed for its use in cases of premature rupture of membranes or chorio-amnionitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical role of amnio-infusion. Ouzounian, JG., Paul, RH.[2019]

Two cases of fatal amniotic fluid embolism occurred in women who underwent saline amnioinfusion during labor, particularly after thick meconium staining was observed, raising concerns about the safety of this intervention in such situations.

While amniotic fluid embolism is rare, the cases suggest a potential link between amnioinfusion and increased risk, especially in the presence of rapid labor and meconium-stained fluid, warranting further investigation without immediate changes to clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic fluid embolism after saline amnioinfusion: two cases and review of the literature. Maher, JE., Wenstrom, KD., Hauth, JC., et al.[2015]

In a study of 313 transabdominal amnioinfusion procedures involving 126 patients, no maternal deaths occurred, indicating a high level of safety for the procedure.

While there were some adverse events, including seven severe fetal complications, the overall low incidence of serious maternal or fetal adverse events suggests that amnioinfusion can be performed with minimal risk, encouraging its use in challenging cases of oligohydramnios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transabdominal amnioinfusion: An evaluation of its adverse events. Nagai, R., Takahashi, Y., Iwagaki, S., et al.[2022]

A survey of 78 academic obstetrics and gynecology departments in the U.S. revealed that amnioinfusion is performed with a variety of protocols and is associated with few complications, indicating its relative safety.

The study found no significant relationship between the method of amnioinfusion or the number of procedures performed and the incidence of complications, suggesting that amnioinfusion can be safely implemented across different practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amnioinfusion survey: prevalence, protocols, and complications. Wenstrom, K., Andrews, WW., Maher, JE.[2019]

Transabdominal amnioinfusion, performed at 32 weeks of gestation, successfully improved fetal imaging by allowing for the identification of structures that were previously obscured due to anhydramnion.

The procedure also resolved diastolic block issues in the fetal aorta and umbilical artery, highlighting its potential to enhance fetal monitoring and diagnosis in cases of severe oligohydramnion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic transabdominal amnioinfusion in a case of anhydramnion and fetal kidney dysplasia. Palo, P., Erkkola, R., Piiroinen, O., et al.[2016]

Amnioinfusion using warm saline and indigo carmine allowed for successful and comprehensive ultrasound evaluations in all 13 patients with severe oligohydramnios, enabling definitive diagnoses.

This technique was particularly effective in both second and early third trimester pregnancies, demonstrating its utility in improving diagnostic capabilities in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amnioinfusion: an aid in the ultrasonographic evaluation of severe oligohydramnios in pregnancy. Quetel, TA., Mejides, AA., Salman, FA., et al.[2019]

In a study of 92 antenatal amnioinfusion procedures, the technique was successful in 95% of cases and significantly increased amniotic fluid levels, aiding in the diagnosis of fetal anomalies.

The procedure was found to be safe, with only 2.2% of infusions leading to clinical amnionitis, and it provided valuable diagnostic information that changed the etiologic diagnosis in 13% of subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic and therapeutic transabdominal amnioinfusion in oligohydramnios. Fisk, NM., Ronderos-Dumit, D., Soliani, A., et al.[2016]

Fetal intraperitoneal infusion of saline in two patients with severe oligohydramnios at 24 and 25 weeks' gestation successfully improved the visualization of intra-abdominal organs, aiding in diagnosis.

This technique offers a viable alternative to artificial amniotic fluid instillation for diagnosing conditions related to severe oligohydramnios, such as renal agenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visualization of fetal intra-abdominal organs in second-trimester severe oligohydramnios by intraperitoneal infusion. Nicolini, U., Santolaya, J., Hubinont, C., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Amnioinfusions to Treat Early Onset Anhydramnios Caused by Renal Anomalies: Background and Rationale for the Renal Anhydramnios Fetal Therapy Trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Successful in utero intervention for bilateral renal agenesis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Prophylactic amnioinfusion as a treatment for oligohydramnios in laboring patients: a prospective, randomized trial. [2019]

4. Denmark pubmed.ncbi.nlm.nih.gov

Two infants with bilateral renal agenesis who were bridged by chronic peritoneal dialysis to kidney transplantation. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Clinical role of amnio-infusion. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Amniotic fluid embolism after saline amnioinfusion: two cases and review of the literature. [2015]

7. Ireland pubmed.ncbi.nlm.nih.gov

Transabdominal amnioinfusion: An evaluation of its adverse events. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Amnioinfusion survey: prevalence, protocols, and complications. [2019]

9. Finland pubmed.ncbi.nlm.nih.gov

Diagnostic transabdominal amnioinfusion in a case of anhydramnion and fetal kidney dysplasia. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Amnioinfusion: an aid in the ultrasonographic evaluation of severe oligohydramnios in pregnancy. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Diagnostic and therapeutic transabdominal amnioinfusion in oligohydramnios. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Visualization of fetal intra-abdominal organs in second-trimester severe oligohydramnios by intraperitoneal infusion. [2019]