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Serial Amnioinfusions for Low Amniotic Fluid (RAFT Trial)
RAFT Trial Summary
This trial offers an experimental therapy to pregnant women with a diagnosis of early pregnancy renal anhydramnios, where the fetus does not have any amniotic fluid. The therapy is repeated or serial "amnioinfusions" of fluid into the womb, which is a risky procedure that may lead to early rupture of membranes and delivery. If the fetus survives, they will require intensive medical management and follow up.
RAFT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRAFT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RAFT Trial Design
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Who is running the clinical trial?
Media Library
- I have consulted with specialists in kidney, newborn care, transplant, surgery, pregnancy issues, social work, and genetics.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 have depression that hasn't improved with treatment, confirmed by a test score.You have signs of chorioamnionitis or abruptio placentae.There are signs that the bag of waters around the baby has broken or separated from the uterus.The pregnant woman has a serious health problem.You are unable to have amnioinfusion due to technical reasons.There are signs that the baby may be born too early.My genetic tests show no significant abnormal findings.My cervix is shorter than 2.5 cm.The baby has other major birth defects.I am an expectant mother and I am 18 years old or older.
- Group 1: Serial amnioinfusions with isotonic fluid
- Group 2: Expectant
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the minimum age requirement for this experiment below thirty?
"This study is limited to adults aged 18-60, with 378 trials available for minors and 987 for seniors."
Is the utilization of Serial amnioinfusions with isotonic fluid authorized by the FDA?
"Our experts at Power believe that serial amnioinfusions with isotonic fluid is only marginally safe, resulting in a score of 1. This treatment has had limited testing regarding its efficacy and safety properties."
What are the criteria for participation in this research?
"This medical trial is recruiting 70 candidates who have been diagnosed with multicystic dysplastic kidney, and are of age between 18-60. Furthermore, expectant mothers must not opt for termination, sign the consent form prior to 26 weeks gestation age (GA), receive initial amnioinfusion before 26 weeks GA in case of fetal renal failure(except bilateral renal agenesis) , agree to be followed up at a RAFT center during pregnancy and postnatal care until discharge."
How many facilities are currently hosting this research endeavor?
"At present, 10 clinical trial sites are conducting this research. These locations include Los Angeles, Stanford and Aurora in addition to 7 other cities across the nation. To reduce travelling demands associated with enrollment, it is recommended that you select a site near your location."
Are any individuals currently enrolling in this clinical experimentation?
"Affirmative. Per the details presented on clinicaltrials.gov, this study is presently enrolling volunteers; it was initially posted in March of 2017 and last modified in November 2022. 70 subjects need to be recruited from 10 distinct medical centres."
What is the current participant count of this experiment?
"Affirmative, clinicaltrials.gov displays that this medical trial is actively recruiting patients and has been doing so since 18th March 2017. 70 individuals are needed from 10 different facilities, the information of which was recently updated on 10th November 2022."
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