Detecting Early Onset Pre-eclampsia and Use of Placental Growth Factor (PlGF) for Marker of Trisomy 21 (PlGF)

Study for the Evaluation of the Benefits of 1 st Trimester Risk Markers in Detecting Early Onset Pre-eclampsia and the Use of the Placental Growth Factor (PlGF) as a Potential Marker for Trisomy 21 and Other Aneuploidies

This is a study for the evaluation of the benefits of 1 st Trimester risk markers in detecting Early Onset Pre-eclampsia and the use of the Placental Growth factor(PIGF) as a potential marker for Trisomy 21 and other aneuploidies.

Aim of this prospective nonprofit study is to analyze the benefits of early onset pre eclampsia risk assessment in the 1st trimester (measuring biochemical markers [PIGF], blood pressure and Doppler ultrasound), and how the results can permit to modify or influence the course of the preeclampsia during the pregnancy. The investigators will also evaluate the potential use of the PIGF as a marker to improve the prenatal screening with the currently used nuchal translucency, serum Pregnancy-associated plasma protein A (PAPP-A) and free beta subunit of human chorionic gonadotropin (fBhCG) parameters.

Study Overview

• Status: Terminated
• Conditions: Pregnancy

• Study Type: Observational
• Enrollment (Actual): 370

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4P2S4
      • OVO Prénatal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women in 1st trimester of pregnancy coming to clinique OVO for prenatal screening

Description

Inclusion Criteria:

• Singleton pregnancy
• Nulliparous pregnancy
• Gestation age between 6.0-13.6 weeks by last menstrual period verified by ultrasound
• Blood sample provided at gestational age 6.0-13.6 weeks
• Informed Consent

Exclusion Criteria:

• Multi-fetal pregnancy
• Primiparous or multiparous pregnancy
• Mental retardation or other mental disorders that impose doubts regarding the true patient's willingness to participate in the study
• Gestation age below 6.0 or above 13.6 weeks by last menstrual period verified by ultrasound.
• Lack of blood sample at the specified enrollment period
• Known major fetal anomaly or fetal demise
• Lack of demographic data

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
study group; patients coming to clinique OVO in the 1st trimester of pregnancy to undergo prenatal screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
levels of Placental Protein 13 (PP13) , PIGF, PAPP-A, PIBF	levels of PP13, PIGF, PAPP-A will de considered in association with Doppler ultrasound and standardised blood pressure measurements to see if they can be used as early risk markers in patients having a delivery before 34 weeks gestation	6-13.6 wks gestation

Collaborators and Investigators

• Sponsor: Clinique Ovo
• Investigators: Principal Investigator: Robert Hemmings, MD, Clinique OVO; Study Director: Bernard Couturier, MD, Clinique OVO; Study Chair: Dominique Berube, PhD, Clinique OVO

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: July 5, 2011
• First Posted (Estimate): July 6, 2011

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 24, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Pregnancy Complications; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Hypertension, Pregnancy-Induced; Chromosome Aberrations; Aneuploidy; Chromosome Duplication; Down Syndrome; Eclampsia; Pre-Eclampsia; Trisomy
• Other Study ID Numbers: B-PRN-10-01