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NCT Number: NCT04940260

Soluble Factors and Renal Outcome in Preeclampsia

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine,Vajira Hospital

Bangkok, 10300, Thailand

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Renal function

Diagnostic Test

measure eGFR at one year post partum

proteinuria

Diagnostic Test

measure urine protein creatinine ratio at one year postpartum

Primary outcomes

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

    Time frame: 1 year

    measure serum sFlt-1/PIGF and eGFR

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

    Time frame: 1 year

    measure serum sFlt-1/PIGF and blood pressure

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

    Time frame: 1 year

    measure serum sFlt-1/PIGF and UACR

  4. Correlation between serum endoglin with long term renal function in preeclampsia

    Time frame: 1 year

    measure endoglin and eGFR

  5. Correlation between serum endoglin with blood pressure in preeclampsia

    Time frame: 1 year

    measure endoglin and blood pressure

  6. Correlation between serum endoglin with level of proteinuria in preeclampsia

    Time frame: 1 year

    measure endoglin and UPCR

Sponsors and collaborators

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jun 25, 2021
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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