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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
History of Changes
  Purpose

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
Preeclampsia

Study Type: Observational
Study Design: 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

Further study details as provided by CHA University:

Primary Outcome Measures:
  • identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio [ Time Frame: at delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • identification of patients at risk for late-onset preeclampsia with combined biochemical markers [ Time Frame: at delivery ] [ Designated as safety issue: Yes ]

Enrollment: 262
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years
Genders 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.

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dong Hyun Cha, professor, CHA University
ClinicalTrials.gov Identifier: NCT01649128     History of Changes
Other Study ID Numbers: PrePark
Study First Received: July 19, 2012
Last Updated: July 24, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by CHA University:
preeclampsia

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

ClinicalTrials.gov processed this record on June 17, 2013