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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether amnioinfusion (amniotic fluid infusion) can aid fetuses with severe kidney problems that cause low amniotic fluid levels. Low fluid can hinder lung development and lead to significant health issues for the baby. Researchers aim to determine if regular fluid addition can improve survival chances until the baby can undergo dialysis or a kidney transplant. Expectant mothers with severe low fluid due to fetal kidney issues, who are willing to give birth and receive care at a specific hospital in Dallas, might be suitable candidates. Participants will receive the amnioinfusion treatment and undergo close monitoring to assess its effects. As an unphased trial, this study offers a unique opportunity for expectant mothers to contribute to groundbreaking research that could improve outcomes for babies with kidney issues.

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 prior data suggests that this procedure is safe for fetuses with kidney anomalies?

Research has shown that amnioinfusion, a procedure where fluid is added around a baby in the womb, holds promise for treating severe kidney problems in unborn babies. Studies have found that this procedure can increase the chances of survival for newborns with conditions causing low levels of amniotic fluid, which is crucial for lung development.

Early findings suggest that amnioinfusion is generally safe for both mother and baby. Specifically, one study examined 21 cases where mothers and their babies received multiple amnioinfusions due to severe kidney issues. The results were positive, with the procedure being safely performed and showing potential benefits for the baby's health.

Overall, while more research is needed to fully understand all the risks, current evidence suggests that amnioinfusion can be a safe option for managing serious kidney problems in unborn babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about amnioinfusion for fetal kidney anomalies because it offers a unique approach that could improve outcomes for affected fetuses. Unlike standard care, which often includes expectant management and comfort care, amnioinfusion involves introducing a saline solution into the amniotic sac. This technique aims to enhance the environment for fetal development, potentially improving kidney function and overall fetal health. By directly addressing the immediate surroundings of the fetus, amnioinfusion could provide benefits that traditional methods do not.

What evidence suggests that amnioinfusion is effective for fetal kidney anomalies?

Research has shown that adding fluid to the amniotic sac, a procedure called serial amnioinfusion, may help fetuses with severe kidney problems survive. In this trial, participants in the experimental arm will undergo serial amnioinfusion in addition to routine care. Studies have found that this procedure can aid lung development, which is often an issue when there is insufficient amniotic fluid. Reviewing similar cases, outcomes improved when amnioinfusion was used. Specifically, these studies suggest better chances of survival until the baby can receive dialysis or a kidney transplant. Overall, the evidence suggests that amnioinfusion could be a promising treatment for fetal kidney issues. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40682209/

Serial Amnioinfusion Therapy for Treatment of Congenital ... Serial amnioinfusion therapy (SAT) has emerged as a potential mitigatory intervention to adverse perinatal outcomes associated with congenital ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06728228?term=AREA%5BConditionSearch%5D(Multicystic%20dysplastic%20kidney%20OR%20%22MCDK%22%20OR%20%22%20multicystic%20renal%20dysplasia%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=1

NCT06728228 | Amnioinfusion for Fetal Renal Failure 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521693425001002

Serial amnioinfusions as a regenerative therapy for ... This article is a comprehensive review of amniotic fluid, its crucial role in fetal development, particularly lung development, and the ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/pd.6850

Serial Amnioinfusion Therapy for Treatment of Congenital ... This systematic review, developed according to PRISMA guidelines, analyzes the published data on outcomes of SAT for BRA and explores its ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2812481

Neonatal Survival After Serial Amnioinfusions for Bilateral ... Outcomes are reported for 21 maternal-fetal pairs with confirmed anhydramnios due to isolated fetal bilateral renal agenesis without other ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11628636/

Comparison of Serial Amnioinfusion Strategies for Isolated ... Amnioinfusions to treat early onset anhydramnios caused by renal anomalies: background and rationale for the renal anhydramnios fetal Therapy trial. Fetal Diagn ...