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NCT03449823 · ClinicalTrials.gov registry record
Renal Artery Dopplers in Twin Twin Transfusion Syndrome
A clinical trial of Twin Twin Transfusion Syndrome, sponsored by Columbia University.
- Completed
- Registry status
- 24
- Enrollment target
- 1
- Study location
NCT03449823: Completed study of Twin Twin Transfusion Syndrome, sponsored by Columbia University.
NCT03449823 is a study of Twin Twin Transfusion Syndrome that has completed, run by Columbia University. The registered enrollment target is 24 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03449823, a study of Twin Twin Transfusion Syndrome, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Twin-twin transfusion syndrome (TTTS) is a complication affecting 10-15% of monochorionic, diamniotic (MCDA) twin pregnancies. Unevenly distributed blood flow across a shared placental circulation results in a volume-restricted donor twin and a volume-overloaded recipient twin, and TTTS has high perinatal morbidity and mortality without treatment. Differential donor and recipient findings in TTTS can be observed upon ultrasound evaluation. TTTS is classified according to the Quintero staging system, which evaluates amniotic fluid volumes, fetal bladders, Doppler study of the umbilical artery and ductus venosus, and for the presence of hydrops or death. However, due to seemingly complex and variable disease pathophysiology, the Quintero system cannot predict outcomes on a case-by-case basis. Prior studies have associated fetal renal artery Doppler ultrasound measurements with amniotic fluid volume in singleton pregnancies. In fetuses with placental insufficiency, adaptive circulatory changes maintain adequate oxygen delivery to vital organs such as the heart, brain, and adrenals, with a consequent deprivation to splanchnic organs. In the fetal kidney, as vascular resistance increases during hypoxia, renal perfusion decreases proportionately. These changes are reflected in renal artery Doppler findings. As these same adaptations are believed to occur in donor twins, renal artery Doppler studies may also be of value in the TTTS evaluation. This study plans to perform renal artery Doppler assessments in MCDA twins complicated by TTTS, and compare them to measurements in gestational-age equivalent MCDA twins without TTTS. If findings differ significantly, it would support further investigation into the use of renal artery Doppler studies for the evaluation of complicated MCDA twins.
Primary Outcome
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the peak systolic velocity for twin A.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Doppler ultrasound of fetal renal artery
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-09-09 |
| Est. Completion | 2018-06-30 |
What the finished NCT03449823 record still lists
NCT03449823 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target.
The record links to 1 condition, with Twin Twin Transfusion Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Doppler ultrasound of fetal renal artery is the first listed.
NCT03449823 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03449823 about?
NCT03449823 is a clinical study titled "Renal Artery Dopplers in Twin Twin Transfusion Syndrome". Twin-twin transfusion syndrome (TTTS) is a complication affecting 10-15% of monochorionic, diamniotic (MCDA) twin pregnancies. Unevenly distributed blood flow across a shared placental circulation results in a volume-restricted donor twin and a volume-overloaded recipient twin, and TTTS has high per...
What is the current status of trial NCT03449823?
This trial is currently completed. The enrollment target is 24 participants. The study started on 2016-09-09. Estimated completion is 2018-06-30.
What conditions does trial NCT03449823 study?
This clinical trial studies the following conditions: Twin Twin Transfusion Syndrome.
What interventions are being tested in trial NCT03449823?
The interventions under investigation include: Doppler ultrasound of fetal renal artery (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03449823?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03449823 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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