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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01649128

Enrollment

262

Registered

2012-07-25

Start date

2009-08-31

Completion date

2011-12-31

Last updated

2012-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

preeclampsia

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 39 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results