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

Tracking Information
First Received Date ^ICMJE	July 19, 2012
Last Updated Date	July 24, 2012
Start Date ^ICMJE	August 2009
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 24, 2012)	identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio [ Time Frame: at delivery ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01649128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 24, 2012)	identification of patients at risk for late-onset preeclampsia with combined biochemical markers [ Time Frame: at delivery ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Screening for Preeclampsia With Various Markers in Low-risk Pregnancy Populations
Official Title ^ICMJE	Screening Models for Early Detection of Late-onset Preeclampsia With Various Markers in Low-risk Pregnancy Populations
Brief 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.
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).
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	low risk women who had not a risk factor of preeclampsia.
Condition ^ICMJE	Preeclampsia
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	262
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	20 Years to 39 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01649128
Other Study ID Numbers ^ICMJE	PrePark
Has Data Monitoring Committee	Yes
Responsible Party	Dong Hyun Cha, CHA University
Study Sponsor ^ICMJE	CHA University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	CHA University
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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