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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia

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: Observational
• Enrollment (Actual): 262

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio	at delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
identification of patients at risk for late-onset preeclampsia with combined biochemical markers	at delivery

Collaborators and Investigators

• Sponsor: CHA University

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Estimate): July 25, 2012
• Last Update Submitted That Met QC Criteria: July 24, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: preeclampsia
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: PrePark