Text Size

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

This study is currently recruiting participants.
Verified August 2012 by OVO R & D
Sponsor:
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01387776
First received: January 31, 2011
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • levels of Placental Protein 13 (PP13) , PIGF, PAPP-A [ Time Frame: 6-13.6 wks gestation ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 2000
Study Start Date: June 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
study group
patients coming to clinique OVO in the 1st trimester of pregnancy to undergo prenatal screening

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387776

Contacts
Contact: Michael Harnois, M.Sc 514 798 2000 ext 755 m.harnois@cliniqueovo.com
Contact: Cynthia Levesque, M.Sc 514 798 2000 ext 755 c.levesque@cliniqueovo.com

Locations
Canada, Quebec
OVO Prénatal Recruiting
Montreal, Quebec, Canada, H4P2S4
Contact: Shirley Brugerie, director     514 798-2000 ext 753     s.brugerie@cliniqueovo.com    
Principal Investigator: Robert Hemmings, MD            
Principal Investigator: Bernard couturier, MD            
Sponsors and Collaborators
OVO R & D
Investigators
Principal Investigator: Robert Hemmings, MD Clinique OVO
Study Director: Bernard Couturier, MD Clinique OVO
Study Chair: Dominique Berube, PhD Clinique OVO
  More Information

No publications provided

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01387776     History of Changes
Other Study ID Numbers: B-PRN-10-01
Study First Received: January 31, 2011
Last Updated: August 23, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Down Syndrome
Eclampsia
Pre-Eclampsia
Trisomy
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
 Genetic Diseases, Inborn
Hypertension, Pregnancy-Induced
Pregnancy Complications
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Chromosome Duplication
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013