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临床试验/NCT04940260
NCT04940260已完成不适用

Long Term Renal Outcome in Preeclampsia : Role of sFlt-1 / PlGF and Endoglin

Bangkok Metropolitan Administration Medical College and Vajira Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Correlation between serum sFlt-1/PIGF with long term renal function in preeclampsia

研究概览

简要总结

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.

详细描述

This is prospective observational study.Study subjects are pregnant women aged more than 18 years 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).14

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 The exclusion criteria were chronic hypertension before pregnancy ,chronic kidney disease according to KDIGO criteria15 ,twin pregnancies,underlying diabetes mellitus .Of the 42 women enrolled in this trial,we excluded 2 patients who had twin pregnancies and history of diabetes mellitus. Eight women were lost to follow up. The remaining 32 patients completed the study.

Data collection and Laboratory Measurements Baseline demographic and clinical data will be recorded as follows: age, gestational age, blood pressure, medication history, parity. Laboratory data included complete blood count, blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), albumin, alkaline phosphate, lactate dehydrogenase (LDH), 24 -hour urine protein excretion and random urine protein-creatinine ratio. Enzyme-linked immunosorbent assay (ELISAs) for human soluble endoglin, SFlt1, and free PIGF will be conducted in duplicate with the use of commercial kits (R§D Systems).

The ratio of SFlt1:PIGF will be calculated. All the participants will be followed up at 3 months and 1 year in which blood pressure, UACR and serum creatinine will be recorded at each visit.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • chronic hypertension before pregnancy ,chronic kidney disease according to KDIGO criteria ,twin pregnancies,underlying diabetes mellitus

结局指标

主要结局

Correlation between serum sFlt-1/PIGF with long term renal function in preeclampsia

时间窗: 1 year

measure serum sFlt-1/PIGF and eGFR

Correlation between serum sFlt-1/PIGF with level of blood pressure in preeclampsia

时间窗: 1 year

measure serum sFlt-1/PIGF and blood pressure

Correlation between serum sFlt-1/PIGF with level of proteinuria in preeclampsia

时间窗: 1 year

measure serum sFlt-1/PIGF and UACR

Correlation between serum endoglin with long term renal function in preeclampsia

时间窗: 1 year

measure endoglin and eGFR

Correlation between serum endoglin with blood pressure in preeclampsia

时间窗: 1 year

measure endoglin and blood pressure

Correlation between serum endoglin with level of proteinuria in preeclampsia

时间窗: 1 year

measure endoglin and UPCR

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Thananda Trakarnvanich

Associate Professor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

研究点 (1)

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