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NCT03441711 · ClinicalTrials.gov registry record
sFlt-1:PlGF Ratio in Diagnosing Superimposed Preeclampsia
A clinical trial, sponsored by University of Tennessee.
- Completed
- Registry status
- 87
- Enrollment target
NCT03441711: Completed study, sponsored by University of Tennessee.
NCT03441711 is a clinical trial that has completed, run by University of Tennessee. The registered enrollment target is 87 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03441711 has completed, sponsored by University of Tennessee.
- COMPLETED
- Registry status
- 87 participants
- Enrollment target
Study Summary
Preeclampsia: associated with poor placentation, incomplete uteroplacental spiral arteries remodeling. Result: ischemia, re-perfusion injury, oxidative stress. A low-grade systemic inflammatory response is more pronounced in preeclampsia. This results in an imbalance between maternal circulating pro-angiogenic (PlGF \& VEGF) \& anti-angiogenic factors (sFlt-1). PlGF \& VEGF function as vasodilators \& preserve structure \& function of glomerular endothelium. sFlt-1 blocks these actions, resulting in hypertension, endothelial dysfunction \& nephropathy. Various stressors, including hypoxia, villous crowding, angiotensin II, \& oxidative stress are associated with preeclampsia \& mediate secretion of soluble vascular growth factor 1 (sVEGFR-1 or sFlt-1) by GADD45 (Growth Arrest and DNA Damage-45). GADD45 is one of a family of stress-induced genes sFlt-1 releases into maternal circulation. Excess sFlt-1 leads to endothelial dysfunction, hypertension \& proteinuria. Exogenously administered sFlt-1 results in syndrome of nephrotic range proteinuria, hypertension, and glomerular endotheliosis in animal models. Women with preeclampsia tend to have higher sFlt-1 \& lower PlGF, resulting in an increased ratio (sFlt-1:PlGF). The difference is greater in women who develop early-onset preeclampsia (before 34 wks gestation). Verlohren, et al., showed an increased sFlt-1/PlGF ratio in patients with preeclampsia as compared to controls \& patients with chronic/gestational hypertension. Other work has examined the longitudinal changes in the individual values of sFlt-1 \& PlGF over the course of the pregnancy, as well as the ratio. Given the low prevalence of preeclampsia in the population, the positive predictive value remained low, however the negative predictive value approached 97% late in gestation. This suggests that the utility of the sFlt-1/PlGF may be in its ability to rule out preeclampsia. More recently the PROGNOSIS study was designed to investigate the value o
Primary Outcome
result at the point of enrollment; compared to the ratio result at 2-7 days post enrollment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2016-02 |
| Est. Completion | 2020-06-30 |
What the finished NCT03441711 record still lists
NCT03441711 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 87 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03441711 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03441711 about?
NCT03441711 is a clinical study titled "sFlt-1:PlGF Ratio in Diagnosing Superimposed Preeclampsia". Preeclampsia: associated with poor placentation, incomplete uteroplacental spiral arteries remodeling. Result: ischemia, re-perfusion injury, oxidative stress. A low-grade systemic inflammatory response is more pronounced in preeclampsia. This results in an imbalance between maternal circulating pr...
What is the current status of trial NCT03441711?
This trial is currently completed. The enrollment target is 87 participants. The study started on 2016-02. Estimated completion is 2020-06-30.
Who is sponsoring clinical trial NCT03441711?
This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.
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