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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01649128
First Posted: July 25, 2012
Last Update Posted: July 25, 2012
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.
Information provided by (Responsible Party):
Dong Hyun Cha, CHA University
July 19, 2012
July 25, 2012
July 25, 2012
August 2009
December 2011   (Final data collection date for primary outcome measure)
identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio [ Time Frame: at delivery ]
Same as current
No Changes Posted
identification of patients at risk for late-onset preeclampsia with combined biochemical markers [ Time Frame: at delivery ]
Same as current
Not Provided
Not Provided
 
Screening for Preeclampsia With Various Markers in Low-risk Pregnancy Populations
Screening Models for Early Detection of Late-onset Preeclampsia With Various Markers in Low-risk Pregnancy Populations
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.
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).
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
low risk women who had not a risk factor of preeclampsia.
Preeclampsia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
262
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
20 Years to 39 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01649128
PrePark
Yes
Not Provided
Not Provided
Dong Hyun Cha, CHA University
CHA University
Not Provided
Not Provided
CHA University
July 2012