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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong Hyun Cha, CHA University
ClinicalTrials.gov Identifier:
NCT01649128
First received: July 19, 2012
Last updated: July 24, 2012
Last verified: July 2012

July 19, 2012
July 24, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01649128 on ClinicalTrials.gov Archive Site
identification of patients at risk for late-onset preeclampsia with combined biochemical markers [ Time Frame: at delivery ] [ Designated as safety issue: Yes ]
Same as current
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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
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Probability Sample

low risk women who had not a risk factor of preeclampsia.

Preeclampsia
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*   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
Female
20 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01649128
PrePark
Yes
Dong Hyun Cha, CHA University
CHA University
Not Provided
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CHA University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP