sFlt-1:PlGF Ratio in Diagnosing Superimposed Preeclampsia
Public ClinicalTrials.gov record NCT03441711. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
The Utility of the sFlt-1/PlGF Ratio in Diagnosing Superimposed Preeclampsia and Predicting Adverse Outcomes in Subjects With Chronic Hypertension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 of the sFlt-1/PlGF ratio for the prediction of the presence or absence of preeclampsia in the short term \& found that a cutoff point of 38 for the sFlt-1/PlGF ratio is useful for predicting the short-term absence of preeclampsia in women with suspected disease (Negative predictive value 99.3% for ruling out preeclampsia within 1 week). Hypothesis: In women with chronic hypertension, the sFlt-1/PlGF ratio will better predict the development of superimposed preeclampsia than clinical criteria alone.
Study identification
- NCT ID
- NCT03441711
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 87 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 14 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2016
- Primary completion
- Jun 29, 2020
- Completion
- Jun 29, 2020
- Last update posted
- Nov 12, 2020
2016 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regional One Health Center for High Risk Pregnancies | Memphis | Tennessee | 38120 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03441711, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 12, 2020 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03441711 live on ClinicalTrials.gov.