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CompletedNCT01649128Updated Jul 25, 2012

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

An observational study in Preeclampsia, sponsored by CHA University. Completed. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2012-07-25.

Sponsored by CHA University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
262
Ages
20 Years to 39 Years
Sex
Female
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Study 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.

Read the 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).

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Conditions studied

  • Preeclampsia

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Keywords

  • preeclampsia
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In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's enrollment of 262 is above the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

CHA University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
262 participants (actual)
06

What researchers measure

Primary outcomes

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

    Time frame: at delivery

Secondary outcomes

  1. identification of patients at risk for late-onset preeclampsia with combined biochemical markers

    Time frame: at delivery

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01649128
Lead sponsor
CHA University
Responsible party
Dong Hyun Cha (professor, CHA University) — Principal investigator
First posted
Jul 25, 2012
Start date
Aug 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Jul 25, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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