Trial Summary
What is the purpose of this trial?This trial tests a method of injecting fluid into the womb of pregnant women whose fetuses have a severe kidney condition that prevents normal lung development. The goal is to help the fetus's lungs grow so they can survive after birth. The trial focuses on the safety and effectiveness of this treatment for fetuses with urinary tract issues.
Is the treatment Serial amnioinfusions with isotonic fluid a promising treatment for low amniotic fluid?Yes, Serial amnioinfusions with isotonic fluid is a promising treatment for low amniotic fluid. Studies show it can reduce the need for cesarean sections, improve the baby's condition at birth, and decrease the mother's hospital stay. It also helps increase the amount of amniotic fluid, which is important for the baby's health.12367
What safety data exists for serial amnioinfusions for low amniotic fluid?The safety data for amnioinfusion, including serial amnioinfusions, suggests it is generally safe with few adverse effects. Studies have shown benefits such as reduced postpartum endometritis, decreased cesarean delivery rates due to fetal distress, and improved amniotic fluid volume. No significant untoward effects were identified in trials, and it was associated with decreased intrapartum morbidity. However, rare cases of amniotic fluid embolism have been reported, indicating the need for further research.235810
What data supports the idea that Serial Amnioinfusions for Low Amniotic Fluid is an effective treatment?The available research shows that Serial Amnioinfusions for Low Amniotic Fluid can be effective. In one study, patients who received amnioinfusion had fewer cesarean sections due to fetal distress compared to those who did not receive the treatment (4.7% vs 16%). Another study found that patients receiving amnioinfusion had significantly less need for surgical intervention and fewer cesarean sections. Additionally, the amniotic fluid volume increased significantly after the treatment, which is beneficial for the pregnancy. These findings suggest that Serial Amnioinfusions can improve outcomes for both the mother and the baby.12349
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
Eligibility Criteria
This trial is for pregnant women over 18 with a fetus diagnosed with EPRA, excluding bilateral renal agenesis. They must be before 22 weeks gestation, not planning to terminate the pregnancy, and able to start treatment before 26 weeks. Participants need to deliver at a RAFT center and agree to postnatal care there.Inclusion Criteria
My baby has been diagnosed with renal failure, not due to missing kidneys, with no amniotic fluid before 22 weeks.
I do not plan to terminate my pregnancy.
I am an expectant mother and I am 18 years old or older.
Exclusion Criteria
I have depression that hasn't improved with treatment, confirmed by a test score.
My genetic tests show no significant abnormal findings.
My cervix is shorter than 2.5 cm.
Treatment Details
The RAFT Trial tests serial amnioinfusions of isotonic fluid into the womb against standard monitoring without infusions. The goal is for the infused fluid to help fetal lung growth in cases where kidney issues have led to low amniotic fluid levels.
2Treatment groups
Experimental Treatment
Active Control
Group I: Serial amnioinfusions with isotonic fluidExperimental Treatment3 Interventions
There are two interventional arms to the trial. Recruitment in the bilateral renal agenesis arm of the trial was stopped in July 2022 after DSMB review.
Recruitment is ongoing in the non-bilateral renal agenesis, fetal renal failure with anhydramnios arm of the trial. Patients will undergo amnioinfusions with isotonic fluid every 2-12 days.. A spinal needle will be used to perform the infusion. The latest infusions will begin is 26 weeks gestation. Standard postnatal care will occur at a RAFT center.
Group II: ExpectantActive Control1 Intervention
Patients will be observed serially by ultrasound, fetal echocardiogram and MRI. Standard postnatal care will occur at a RAFT center.
Isotonic fluid is already approved in United States for the following indications:
🇺🇸 Approved in United States as Isotonic fluid for:
- Experimental treatment for early pregnancy renal anhydramnios (EPRA)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Johns HopkinsBaltimore, MD
University of Southern California/Children's Hospital of Los Angeles/Huntington HospitalLos Angeles, CA
Stanford UniversityStanford, CA
University of California San FranciscoSan Francisco, CA
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Prophylactic intrapartum amnioinfusion for patients with oligohydramnios. A prospective randomized study. [2004]This prospective study evaluated whether prophylactic saline amnioinfusion among patients with amniotic fluid index (AFI)
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.
A prospective randomized study of saline solution amnioinfusion. [2019]We performed a prospective randomized study of saline solution amnioinfusion in four types of pregnancy complications: postterm pregnancy, variable decelerations in labor, preterm labor, and oligohydramnios-suspected growth retardation. A total of 100 patients were randomized, 43 to undergo amnioinfusion and 57 to be in a control group. Patients undergoing amnioinfusion had a significantly decreased incidence of postpartum endometritis (2.4% vs 19%, p = 0.01) and a lower incidence of cesarean delivery that was due to fetal distress in labor (4.7% vs 16%, p = 0.07). The use of amnioinfusion also made a significant contribution to the four-quadrant ultrasonographic estimate of amniotic fluid volume (14.7 vs 9.8 cm, p less than 0.001). All other maternal and neonatal outcome parameters were similar between the two groups. We conclude that saline solution amnioinfusion in labor may be a beneficial procedure but that further studies are needed.
Amniotic fluid volume increase after amnioinfusion of a fixed volume. [2019]Amnioinfusion of 250 ml of normal saline solution was performed in 30 laboring women at greater than or equal to 37 weeks' gestation with oligohydramnios as defined by an amniotic fluid index of less than or equal to 5 cm. A total of 50 amnioinfusions were performed. Amniotic fluid volumes, as assessed by the amniotic fluid index, increased by a mean of 4.3 +/- 1.5 cm after infusion. We conclude that in women with oligohydramnios, 250 ml of amnioinfusate will increase the amniotic fluid index by approximately 4 cm.
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.
Intrapartum amnioinfusion in twin gestation. A preliminary report of three cases. [2015]Amnioinfusion is an intrapartum technique that is not usually attempted in twin gestations. This report describes infusion of normal saline into the amniotic sacs of three twin gestations with oligohydramnios. All the twins were safely delivered vaginally. No untoward effects were noted. Ultrasound is advised following amnioinfusion to assess the increase in the amniotic fluid volume.
Amnioinfusion. [2019]Abnormal amniotic fluid volume may be both the result and the cause of complications at various stages of pregnancy. This review focuses on evidence from randomised trials of the effectiveness of amnioinfusion. Attempts to prevent the development of pulmonary hypoplasia by means of transabdominal amnioinfusion to correct severe oligohydramnios in the middle trimester of pregnancy have not been evaluated by randomised trials. Long-term transcervical amnioinfusion for prelabour rupture of the membranes has shown promising results in prospective studies, but has also not been subjected to randomised evaluation. Transcervical amnioinfusion during labour is a relatively simple procedure. Normal saline is infused through an intrauterine catheter, preferably one with a catheter-tip pressure transducer. Once an adequate volume of amniotic fluid has been achieved, it is maintained by means of a slow continuous infusion or repeated bolus infusions. Amnioinfusion has been used to prevent or treat fetal heart rate (FHR) decelerations thought to be due to oligohydramnios. In several rather small randomised trials, amnioinfusion has been associated with a reduction in FHR decelerations, caesarean sections, low Apgar scores, low umbilical arterial pH values and postpartum endometritis. Amnioinfusion has also been used to dilute thick meconium-staining of the amniotic fluid. In trials for this indication, amnioinfusion has been associated with similar benefits, and in addition a reduction in meconium presence below the vocal cords, meconium aspiration syndrome and the need for neonatal ventilation. Larger trials are needed to determine whether amnioinfusion is associated with an effect on perinatal mortality, and whether complications such as umbilical cord prolapse are increased.
Fetal electrolyte and acid-base responses to amnioinfusion: lactated Ringer's versus normal saline in the ovine fetus. [2019]We hypothesized that amnioinfusion with normal saline would increase fetal plasma sodium and chloride concentrations, resulting in a hyperchloremic acidosis, and that these alterations would not occur after amnioinfusion with lactated Ringer's solution.
Effect of maternal hydration on oligohydramnios: a comparison of three volume expansion methods. [2019]To determine the effect of maternal hydration with intravenous (i.v.) isotonic fluid, i.v. hypotonic fluid, and oral water on amniotic fluid index (AFI) in women with oligohydramnios.
Prophylactic amnioinfusion in preganancies complicated by chorioamnionitis: a prospective randomized trial. [2015]The objective of this article is to prospectively investigate the efficacy of amnioinfusion as a means to reduce febrile morbidity in pregnancies complicated by chorioamnionitis. All laboring patients with a temperature > or =100.1 degrees F were approached for study participation. Exclusion criteria included amnionitis diagnosed at greater than 8 cm dilation, multiple gestation, placental abruption, or a nonreassuring fetal heart rate tracing. Consenting patients were randomized to receive antibiotics (ampicillin or penicillin with gentamicin) and acetaminophen with or without amnioinfusion. All patients received intrauterine pressure catheter placement. For study patients, normal saline at room temperature was infused at 10 mL/min for 60 min, then 3 mL/min until delivery. Postpartum endometritis was defined as a temperature = 100.4 degrees F accompanied by uterine tenderness more than 12 hr after delivery. Statistical analysis was performed using the Student's t-test for continuous data and Chi-square for discrete variables. Thirty-six patients were enrolled, and complete data were available for 34 patients (17 in each group). There were no differences between groups with respect to maternal age, gravidity, race, or gestational age. There were also no differences between groups in duration of rupture of membranes, temperature at randomization, interval from randomization to delivery, cesarean section rate, or umbilical cord arterial pH. The mean temperature at the time of delivery was 99.8+/-0.9 degrees F for the amnioinfusion group versus 100.5+/-1.0 degrees F for the control group (p=0.046). Three of 17 amnioinfusion patients and 3 of 17 control patients had postpartum endometritis. There was 1 neonatal infection in the treatment group and no neonatal infections among the control patients. Prophylactic amnioinfusion was associated with a decline in temperature at the time of delivery. No untoward effects from the amnioinfusion were identified.