Screening for Preeclampsia With Various Markers in Low-risk Pregnancy Populations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01649128
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : July 25, 2012
Information provided by (Responsible Party):
Dong Hyun Cha, CHA University

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.

Condition or disease

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).

Study Type : Observational
Actual Enrollment : 262 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening Models for Early Detection of Late-onset Preeclampsia With Various Markers in Low-risk Pregnancy Populations
Study Start Date : August 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio [ Time Frame: at delivery ]

Secondary Outcome Measures :
  1. identification of patients at risk for late-onset preeclampsia with combined biochemical markers [ Time Frame: at delivery ]

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
low risk women who had not a risk factor of preeclampsia.

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

Responsible Party: Dong Hyun Cha, professor, CHA University Identifier: NCT01649128     History of Changes
Other Study ID Numbers: PrePark
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: July 2012

Keywords provided by Dong Hyun Cha, CHA University:

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications