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.
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.
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.12345
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.12678
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.123910
Research Team
Meredith Atkinson
Principal Investigator
Johns Hopkins University
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
Exclusion Criteria
Treatment Details
Interventions
- Isotonic fluid (Drug)
- Serial amnioinfusions with isotonic fluid (Procedure)
- Spinal needle (Device)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator