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

Preeclampsia Clinical Trial

Official title:

Screening Models for Early Detection of Late-onset Preeclampsia With Various Markers in Low-risk Pregnancy Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649128
• Other study ID #: PrePark
• Status: Completed
• Phase: N/A
• First received: July 19, 2012
• Last updated: July 24, 2012
• Start date: August 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio		at delivery	Yes
Secondary	identification of patients at risk for late-onset preeclampsia with combined biochemical markers		at delivery	Yes