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Renal Anhydramnios Fetal Therapy
NCT03101891 · View on ClinicalTrials.gov ↗
Study Summary
Early pregnancy renal anhydramnios (EPRA) is a condition where a pregnant woman does not have any amniotic fluid around her fetus because of a problem with the fetus's kidneys. This condition is thought to be fatal once the fetus is born because of inadequate lung growth. The Renal Anhydramnios Fetal Therapy (RAFT) Trial offers eligible pregnant women with a diagnosis of EPRA an experimental therapy of repeated or serial "amnioinfusions" of fluid into the womb. An amnioinfusion involves placing a small needle through the pregnant woman's skin into the womb next to the fetus. Warm sterile fluid with balanced electrolytes and antibiotics is then slowly infused into amniotic space inside the womb. The aim is to help the fetus's lungs grow enough so he or she can survive after birth. These amnioinfusions will be carried out by an expert in fetal interventions at a RAFT center. There is a significant risk of early rupture of membranes and early delivery in subjects who receive amnioinfusions, and any potential trial participants will be counseled about these risks before they decide whether to join the trial. Any eligible patients who, after counseling, elect to terminate the pregnancy will not be eligible to participate in the trial. All eligible patients who choose to join the RAFT trial will be able to choose their assignment into one of two arms of the study: (1) to receive serial amnioinfusions (2) to not receive amnioinfusions but receive monitoring for the remainder of the pregnancy at the RAFT center. Thus, assignment of patients to study arm will not be random, but will be decided by the participant. Fetuses who do survive after birth will require intensive medical management for kidney failure including placement of a dialysis catheter and dialysis therapy with the eventual need for a kidney transplant. Treatment for lung disease secondary to abnormal lung development may also be required. The study will follow babies and their families until non-survival or tr
Conditions Studied
Interventions
- PROCEDURE Serial amnioinfusions with isotonic fluid
- DEVICE Spinal needle
- DRUG Isotonic fluid
Study Locations (9)
California
- University of Southern California/Children's Hospital of Los Angeles/Huntington Hospital — Los Angeles
- University of California San Francisco — San Francisco
- Stanford University — Stanford
Colorado
- University of Colorado Denver — Aurora
Maryland
- Johns Hopkins Hospital — Baltimore
Minnesota
- Mayo Clinic — Rochester
New York
- Columbia University — New York
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Texas
- University of Texas Health Science Center at Houston — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2030-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03101891
The ClinicalTrials.gov registry entry for NCT03101891 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,517 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Lower Urinary Tract Obstructive Syndrome appearing as the primary indexed condition, and to 3 interventions — of which Serial amnioinfusions with isotonic fluid is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03101891 reports 9 study locations spanning 7 distinct geographic areas — top geographies include California, Colorado, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03101891 about?
NCT03101891 is a clinical study titled "Renal Anhydramnios Fetal Therapy". Early pregnancy renal anhydramnios (EPRA) is a condition where a pregnant woman does not have any amniotic fluid around her fetus because of a problem with the fetus's kidneys. This condition is thought to be fatal once the fetus is born because of inadequate lung growth. The Renal Anhydramnios Feta...
What is the current status of trial NCT03101891?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2018-12-21. Estimated completion is 2030-02-28.
What conditions does trial NCT03101891 study?
This clinical trial studies the following conditions: Lower Urinary Tract Obstructive Syndrome, Multicystic Dysplastic Kidney, Fetal Renal Anomaly, Anhydramnios, Potter Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03101891?
The interventions under investigation include: Serial amnioinfusions with isotonic fluid (PROCEDURE), Spinal needle (DEVICE), Isotonic fluid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03101891?
This trial is sponsored by Johns Hopkins University, which has 1,517 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03101891 being conducted?
This trial has 9 study locations across California, Colorado, Maryland, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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