We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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

Resource links provided by NLM:


Further study details as provided by Dong Hyun Cha, CHA University:

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
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

Responsible Party: Dong Hyun Cha, professor, CHA University
ClinicalTrials.gov Identifier: NCT01649128     History of Changes
Other Study ID Numbers: PrePark
First Submitted: July 19, 2012
First Posted: July 25, 2012
Last Update Posted: July 25, 2012
Last Verified: July 2012

Keywords provided by Dong Hyun Cha, CHA University:
preeclampsia

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


To Top