Amnioinfusion for Fetal Kidney Anomalies
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Fetal Care Center, PLLC
Disqualifiers: Cervix <2.5 cm, Trisomy 13/18, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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?
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
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.
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Trial 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 (Procedure)
Trial OverviewThe 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
Research Locations NearbySelect from list below to view details:
Fetal Care CenterDallas, TX
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Who Is Running the Clinical Trial?
Fetal Care Center, PLLCLead Sponsor
Medical City Children's HospitalCollaborator
Medical City Women's HospitalCollaborator
References
Amnioinfusions to Treat Early Onset Anhydramnios Caused by Renal Anomalies: Background and Rationale for the Renal Anhydramnios Fetal Therapy Trial. [2021]Anhydramnios caused by early anuria is thought to be universally fatal due to pulmonary hypoplasia. Bilateral renal agenesis and early fetal renal failure leading to anhydramnios constitute early pregnancy renal anhydramnios (EPRA). There have been successful reports of amnioinfusions to promote lung growth in the setting of EPRA. Some of these successfully treated EPRA fetuses have survived the neonatal period, undergone successful dialysis, and subsequently received a kidney transplant. Conversely, there are no reports of untreated EPRA survivors. This early success of amnioinfusions to treat EPRA justifies a rigorous prospective trial. The objective of this study is to provide a review of what is known about fetal therapy for EPRA and describe the Renal Anhydramnios Fetal Therapy trial. We review the epidemiology, pathophysiology, and genetics of EPRA. Furthermore, we have performed systematic review of case reports of treated EPRA. We describe the ethical framework, logistical challenges, and rationale for the current single center (NCT03101891) and planned multicenter trial.
Successful in utero intervention for bilateral renal agenesis. [2021]We report a case of bilateral renal agenesis treated with serial amnioinfusion in which the newborn survived the newborn period and was able to undergo peritoneal dialysis as a bridge to planned renal transplantation.
Prophylactic amnioinfusion as a treatment for oligohydramnios in laboring patients: a prospective, randomized trial. [2019]Prophylactic amnioinfusion was studied in a randomized sample of 305 patients with oligohydramnios in labor. One hundred seventy-five patients underwent amnioinfusion with the remainder serving as controls. Amniotic fluid was titrated to an amniotic fluid index greater than 10.0 cm in the treatment group. Patients receiving amnioinfusion had significantly less operative intervention for fetal distress (p = 0.0001) and fewer cesarean sections (p = 0.0001). Umbilical artery pH at the time of delivery also was increased (p = 0.0001). Rates of amnionitis and endometritis were not significantly different between infused patients and controls, although the length of hospital stay was significantly decreased (p = 0.002) in the treatment group. Our data support earlier reports in the literature that amnioinfusion is a useful technique for decreasing intrapartum morbidity for both mother and fetus.
Two infants with bilateral renal agenesis who were bridged by chronic peritoneal dialysis to kidney transplantation. [2021]Bilateral renal agenesis is associated with severe oligohydramnios and was considered incompatible with postnatal life due to severe pulmonary hypoplasia. The use of renal replacement therapy was limited by significant morbidity and mortality associated with dialysis in very young infants with major pulmonary pathology. In the United States, there is a tremendous controversy about whether or not the use of prenatal amniotic fluid infusions provides a benefit to fetuses with bilateral renal agenesis. One of the critical issues identified is that there are, as yet, no children reported who had achieved long-term survival. Previous reports all indicated these children died shortly after birth or after unsuccessful peritoneal dialysis. We present two infants with a prenatal diagnosis of bilateral renal agenesis whose mothers elected to undergo prenatal amnioinfusions. One was born at 28 weeks with a birthweight of 1230 g and the other born at 34 weeks with a birthweight of 1940 g. We present the details of both cases, with initial management on chronic peritoneal dialysis, which started shortly after birth, as a bridge to living related kidney transplants.
Clinical role of amnio-infusion. [2019]Amnio-infusion is a simple, yet beneficial, technique for improving pregnancy outcome. Antepartum amnio-infusion has been shown to be beneficial as an aid to enhancing ultrasonographic fetal imaging and may have a role in the administration of antibiotic therapy or the prevention of pulmonary hypoplasia. There are considerable data to support the intrapartum use of amnio-infusion in the presence of oligohydramnios, variable decelerations or meconium. Numerous prospective clinical trials have shown a significant benefit of amnio-infusion in reducing the rate of emergency caesarean section for fetal distress and complications related to meconium when used for these indications. Additional research is needed to clarify further its intrapartum role in patients with premature rupture of membranes or chorio-amnionitis.
Amniotic fluid embolism after saline amnioinfusion: two cases and review of the literature. [2015]Amnioinfusion is an intrapartum intervention with proven benefit in certain clinical situations. It is thought to be a safe treatment with few adverse effects.
Transabdominal amnioinfusion: An evaluation of its adverse events. [2022]Transabdominal amnioinfusion is beneficial in oligohydramnios, which has high fetal mortality and does not improve with observation alone. However, there are few reports on the maternal adverse events of transabdominal amnioinfusion. This study aimed to evaluate the adverse events of amniocentesis with transabdominal amnioinfusion.
Amnioinfusion survey: prevalence, protocols, and complications. [2019]To determine whether amnioinfusion is associated with labor and delivery complications, and whether complication type and reported incidence are related to infusion method.
Diagnostic transabdominal amnioinfusion in a case of anhydramnion and fetal kidney dysplasia. [2016]Diagnostic transabdominal amnioinfusion was performed at 32 weeks of gestation in a case of anhydramnion. Before saline infusion, no exact fetal structures could be identified by sonography. Also, there was a total diastolic block in the fetal aorta (FA) and umbilical artery (UA). After infusion of 270ml of saline, the diastolic blocks in the FA and UA disappeared, and, after another infusion of 410ml of saline, severe fetal congenital kidney abnormalities were identified. Transabdominal amnioinfusion is a practical aid to fetal sonography in severe oligohydramnion and anhydramnion.
Amnioinfusion: an aid in the ultrasonographic evaluation of severe oligohydramnios in pregnancy. [2019]Amnioinfusion was used in pregnancy complicated by severe oligohydramnios to enable a more comprehensive ultrasonographic evaluation of the pregnancy.
Diagnostic and therapeutic transabdominal amnioinfusion in oligohydramnios. [2016]We report our experience with 92 antenatal amnioinfusion procedures. In order to facilitate ultrasound visualization, a diagnostic infusion was attempted at a median of 22 weeks (range 16-36) in 61 pregnancies with oligohydramnios in the absence of ruptured membranes on clinical examination. The procedure was successful in 58 (95%). Infusion (mean volume 181 mL, range 40-64) significantly increased (P less than .001) the deepest pool of amniotic fluid to a mean of 3.2 cm. Suspected fetal anomalies were then confirmed in 27 of 30 cases, whereas kidneys were clearly demonstrated in three fetuses suspected of renal agenesis. In addition, previously unsuspected anomalies were identified in five. Vaginal leakage indicating ruptured membranes occurred in 16 women. Leakage occurred in zero of 24 patients with, compared to 16 of 35 without, fetal urinary disorders (chi 2 = 15.1, P less than .001), which does not support the recent suggestion that amnioinfusion causes rather than unmasks rupture of the membranes. Membranous detachment was observed by ultrasound in 13 patients, 11 of whom leaked vaginally. Information obtained at amnioinfusion led to a change of etiologic diagnosis in eight (13% of subjects). Forty serial infusions were performed in nine women as a pilot study to prevent oligohydramnios sequelae. There were no skeletal deformities; three neonates survived, and five of the six perinatal deaths had normal lung-body weight ratios. Overall, only two of 89 infusions (2.2%) were complicated by clinical amnionitis. Our findings support a role for amnioinfusion in oligohydramnios.
Visualization of fetal intra-abdominal organs in second-trimester severe oligohydramnios by intraperitoneal infusion. [2019]Fetal intraperitoneal infusion of saline was performed in two patients with severe oligohydramnios at 24 and 25 weeks' gestation in order to enhance visualization of intra-abdominal organs. Renal agenesis was easily diagnosed. The technique can be considered as an alternative to artificial instillation of amniotic fluid in the differential diagnosis of conditions associated with severe oligohydramnios.