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Clinical Trials/NCT01649128
NCT01649128
Completed
Not Applicable

Screening Models for Early Detection of Late-onset Preeclampsia With Various Markers in Low-risk Pregnancy Populations

CHA University0 sites262 target enrollmentAugust 2009
ConditionsPreeclampsia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preeclampsia
Sponsor
CHA University
Enrollment
262
Primary Endpoint
identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

For the prediction of late-onset preeclampsia (PE) in low risk women, the investigators established a cut-off value for sFlt-1/PlGF ratio and evaluated the combination models of Elecys, second trimester uterine artery (UtA) doppler, and fetoplacental proteins for Down syndrome screening.

Detailed Description

A prospective study was carried on in Cha hospital. Serum samples for Down syndrome screening were assayed to estimate pregnancy-associated plasma protein-A (PAPP-A), alpha-fetoprotein , unconjugated estriol, human chorionic gonadotrophin , and inhibin-A. Women screened for Down syndrome were offered UtA Doppler at 20-24 weeks of gestation and then collected serial serum samples for sFlt-1/PlGF ratio at two time points (24-27 and 34-37 weeks' gestation).

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
December 2011
Last Updated
13 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dong Hyun Cha

professor

CHA University

Eligibility Criteria

Inclusion Criteria

  • Women considered as a potential participant in this research were patients regularly visited at the prenatal care of Cha hospital in Seoul, Korea

Exclusion Criteria

  • early onset and cases not to measure the sFlt/PlGF ratio and other markers
  • twin pregnancy
  • Chronic hypertension
  • prior history of preeclampsia
  • pregestational diabetes mellitus
  • gestational diabetes mellitus
  • patients delivered before 35 weeks of gestation
  • preeclamptic patients with onset before 35 weeks of gestation
  • patients with body mass index 25kg/m2 or greater
  • maternal age 40 years older

Outcomes

Primary Outcomes

identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio

Time Frame: at delivery

Secondary Outcomes

  • identification of patients at risk for late-onset preeclampsia with combined biochemical markers(at delivery)

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