Soluble Factors and Renal Outcome in Preeclampsia

NCT04940260 | Completed DMC

• 1 other identifier: 082/61
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Renal Function

Outcome Measures

Primary Outcomes (6)

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

  measure serum sFlt-1/PIGF and eGFR

  1 year

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

  measure serum sFlt-1/PIGF and blood pressure

  1 year

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

  measure serum sFlt-1/PIGF and UACR

  1 year

• Correlation between serum endoglin with long term renal function in preeclampsia

  measure endoglin and eGFR

  1 year

• Correlation between serum endoglin with blood pressure in preeclampsia

  measure endoglin and blood pressure

  1 year

• Correlation between serum endoglin with level of proteinuria in preeclampsia

  measure endoglin and UPCR

  1 year

Interventions

Renal function DIAGNOSTIC_TEST

measure eGFR at one year post partum

proteinuria DIAGNOSTIC_TEST

measure urine protein creatinine ratio at one year postpartum

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women aged more than 18 years more than 24 weeks of gestation who were diagnosed and classified as preeclampsia or gestational hypertension

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bangkok Metropolitan Administration Medical College and Vajira Hospital: lead

Study Sites (1)

Faculty of Medicine,Vajira Hospital

Bangkok, 10300, Thailand

Location

Related Publications (10)

• Bellamy L, Casas JP, Hingorani AD, Williams DJ. Pre-eclampsia and risk of cardiovascular disease and cancer in later life: systematic review and meta-analysis. BMJ. 2007 Nov 10;335(7627):974. doi: 10.1136/bmj.39335.385301.BE. Epub 2007 Nov 1.

  PMID: 17975258 BACKGROUND

• Magee LA, von Dadelszen P. Pre-eclampsia and increased cardiovascular risk. BMJ. 2007 Nov 10;335(7627):945-6. doi: 10.1136/bmj.39337.427500.80. Epub 2007 Nov 1.

  PMID: 17975257 BACKGROUND

• Rudra CB, Williams MA. Monthly variation in preeclampsia prevalence: Washington State, 1987-2001. J Matern Fetal Neonatal Med. 2005 Nov;18(5):319-24. doi: 10.1080/14767050500275838.

  PMID: 16390791 BACKGROUND

• Vikse BE, Irgens LM, Leivestad T, Skjaerven R, Iversen BM. Preeclampsia and the risk of end-stage renal disease. N Engl J Med. 2008 Aug 21;359(8):800-9. doi: 10.1056/NEJMoa0706790.

  PMID: 18716297 BACKGROUND

• McDonald SD, Han Z, Walsh MW, Gerstein HC, Devereaux PJ. Kidney disease after preeclampsia: a systematic review and meta-analysis. Am J Kidney Dis. 2010 Jun;55(6):1026-39. doi: 10.1053/j.ajkd.2009.12.036. Epub 2010 Mar 25.

  PMID: 20346562 BACKGROUND

• Khashan AS, Evans M, Kublickas M, McCarthy FP, Kenny LC, Stenvinkel P, Fitzgerald T, Kublickiene K. Preeclampsia and risk of end stage kidney disease: A Swedish nationwide cohort study. PLoS Med. 2019 Jul 30;16(7):e1002875. doi: 10.1371/journal.pmed.1002875. eCollection 2019 Jul.

  PMID: 31361741 BACKGROUND

• Levine RJ, Maynard SE, Qian C, Lim KH, England LJ, Yu KF, Schisterman EF, Thadhani R, Sachs BP, Epstein FH, Sibai BM, Sukhatme VP, Karumanchi SA. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med. 2004 Feb 12;350(7):672-83. doi: 10.1056/NEJMoa031884. Epub 2004 Feb 5.

  PMID: 14764923 BACKGROUND

• Chaiworapongsa T, Romero R, Kim YM, Kim GJ, Kim MR, Espinoza J, Bujold E, Goncalves 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. doi: 10.1080/14767050400028816.

  PMID: 15804781 BACKGROUND

• 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. doi: 10.1038/nm1429. Epub 2006 Jun 4.

  PMID: 16751767 BACKGROUND

• Taylor RN, Grimwood J, Taylor RS, McMaster MT, Fisher SJ, North RA. Longitudinal serum concentrations of placental growth factor: evidence for abnormal placental angiogenesis in pathologic pregnancies. Am J Obstet Gynecol. 2003 Jan;188(1):177-82. doi: 10.1067/mob.2003.111.

  PMID: 12548214 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Kidney Function Tests

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 25, 2021
• Study Start: October 1, 2019
• Primary Completion: December 15, 2020
• Study Completion: January 31, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

TH (1)