Soluble Factors and Renal Outcome in Preeclampsia

Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04940260
Collaborator
(none)
42
1
16
2.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Renal function
  • Diagnostic Test: proteinuria

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
42 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Long Term Renal Outcome in Preeclampsia : Role of sFlt-1 / PlGF and Endoglin
Actual Study Start Date :
Oct 1, 2019
Actual Primary Completion Date :
Dec 15, 2020
Actual Study Completion Date :
Jan 31, 2021

Outcome Measures

Primary Outcome Measures

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

    measure serum sFlt-1/PIGF and eGFR

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

    measure serum sFlt-1/PIGF and blood pressure

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

    measure serum sFlt-1/PIGF and UACR

  4. Correlation between serum endoglin with long term renal function in preeclampsia [1 year]

    measure endoglin and eGFR

  5. Correlation between serum endoglin with blood pressure in preeclampsia [1 year]

    measure endoglin and blood pressure

  6. Correlation between serum endoglin with level of proteinuria in preeclampsia [1 year]

    measure endoglin and UPCR

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
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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Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine,Vajira Hospital Bangkok Thailand 10300

Sponsors and Collaborators

  • Bangkok Metropolitan Administration Medical College and Vajira Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Thananda Trakarnvanich, Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira Hospital
ClinicalTrials.gov Identifier:
NCT04940260
Other Study ID Numbers:
  • 082/61
First Posted:
Jun 25, 2021
Last Update Posted:
Jun 29, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2021