NCT01649128

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

Enrollment Period

2.3 years

First QC Date

July 19, 2012

Last Update Submit

July 24, 2012

Conditions

Keywords

preeclampsia

Outcome Measures

Primary Outcomes (1)

  • identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio

    at delivery

Secondary Outcomes (1)

  • identification of patients at risk for late-onset preeclampsia with combined biochemical markers

    at delivery

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Women considered as a potential participant in this research were patients regularly visited at the prenatal care of Cha hospital in Seoul, Korea

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 19, 2012

First Posted

July 25, 2012

Study Start

August 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 25, 2012

Record last verified: 2012-07