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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01387776
Recruitment Status : Terminated (The technique has been approved and validated)
First Posted : July 6, 2011
Last Update Posted : July 28, 2015
Information provided by (Responsible Party):

Brief Summary:

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 or disease

Study Type : Observational
Actual Enrollment : 370 participants
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
Study Start Date : June 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

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

Primary Outcome Measures :
  1. levels of Placental Protein 13 (PP13) , PIGF, PAPP-A, PIBF [ Time Frame: 6-13.6 wks gestation ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01387776

Canada, Quebec
OVO Prénatal
Montreal, Quebec, Canada, H4P2S4
Sponsors and Collaborators
Principal Investigator: Robert Hemmings, MD Clinique OVO
Study Director: Bernard Couturier, MD Clinique OVO
Study Chair: Dominique Berube, PhD Clinique OVO

Responsible Party: OVO R & D Identifier: NCT01387776     History of Changes
Other Study ID Numbers: B-PRN-10-01
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Down Syndrome
Hypertension, Pregnancy-Induced
Pregnancy Complications
Chromosome Aberrations
Pathologic Processes
Chromosome Duplication
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action