Preeclampsia Clinical Trial
Official title:
Long Term Renal Outcome in Preeclampsia : Role of sFlt-1 / PlGF and Endoglin
NCT number | NCT04940260 |
Other study ID # | 082/61 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | January 31, 2021 |
Verified date | June 2021 |
Source | Bangkok Metropolitan Administration Medical College and Vajira Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Preeclampsia (PE) is an important complication of pregnancy and can lead to chronic kidney disease by causing endothelial damage and podocyte loss, Soluble forms-like tyrosine kinase-1 (sFlt-1), placental growth factor (PlGF), sFlt1 / PlGF ratio and endoglin are the biomarkers for the differential diagnosis of preeclampsia and other diseases. We aim to explore the correlation of these biomarkers with long term renal function, blood pressure and urine albumin creatinine ratio (UACR) in PE patients.
Status | Completed |
Enrollment | 42 |
Est. completion date | January 31, 2021 |
Est. primary completion date | December 15, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - more than 24 weeks of gestation who were diagnosed and classified as preeclampsia or gestational hypertension by the criteria recommends by the American College of Obstetricians and Gynecologists (ACOG) Severe preeclampsia will be diagnosed by: - A systolic/diastolic blood pressure = 140 mmHg occurring on two occasions at least 4 hours apart after 20 weeks of gestation a women whose blood pressure has previously been normal - Proteinuria with excretion of 0.3 gm or more of protein in a 24 hour urine specimen or urine dipstick results of at least 1+(30 mg per deciliter) on two occasions Exclusion Criteria: chronic hypertension before pregnancy ,chronic kidney disease according to KDIGO criteria ,twin pregnancies,underlying diabetes mellitus - |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine,Vajira Hospital | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Bangkok Metropolitan Administration Medical College and Vajira Hospital |
Thailand,
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Chaiworapongsa T, Romero R, Kim YM, Kim GJ, Kim MR, Espinoza J, Bujold E, Gonçalves L, Gomez R, Edwin S, Mazor M. Plasma soluble vascular endothelial growth factor receptor-1 concentration is elevated prior to the clinical diagnosis of pre-eclampsia. J Matern Fetal Neonatal Med. 2005 Jan;17(1):3-18. — View Citation
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Venkatesha S, Toporsian M, Lam C, Hanai J, Mammoto T, Kim YM, Bdolah Y, Lim KH, Yuan HT, Libermann TA, Stillman IE, Roberts D, D'Amore PA, Epstein FH, Sellke FW, Romero R, Sukhatme VP, Letarte M, Karumanchi SA. Soluble endoglin contributes to the pathogenesis of preeclampsia. Nat Med. 2006 Jun;12(6):642-9. Epub 2006 Jun 4. Erratum in: Nat Med. 2006 Jul;12(7):862. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between serum sFlt-1/PIGF with long term renal function in preeclampsia | measure serum sFlt-1/PIGF and eGFR | 1 year | |
Primary | Correlation between serum sFlt-1/PIGF with level of blood pressure in preeclampsia | measure serum sFlt-1/PIGF and blood pressure | 1 year | |
Primary | Correlation between serum sFlt-1/PIGF with level of proteinuria in preeclampsia | measure serum sFlt-1/PIGF and UACR | 1 year | |
Primary | Correlation between serum endoglin with long term renal function in preeclampsia | measure endoglin and eGFR | 1 year | |
Primary | Correlation between serum endoglin with blood pressure in preeclampsia | measure endoglin and blood pressure | 1 year | |
Primary | Correlation between serum endoglin with level of proteinuria in preeclampsia | measure endoglin and UPCR | 1 year |
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