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

This study has been terminated.
(The technique has been approved and validated)
Sponsor:
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01387776
First received: January 31, 2011
Last updated: July 24, 2015
Last verified: July 2015

January 31, 2011
July 24, 2015
June 2012
June 2015   (final data collection date for primary outcome measure)
levels of Placental Protein 13 (PP13) , PIGF, PAPP-A, PIBF [ 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
levels of 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
Complete list of historical versions of study NCT01387776 on ClinicalTrials.gov Archive Site
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Detecting Early Onset Pre-eclampsia and Use of Placental Growth Factor (PlGF) for Marker of Trisomy 21
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
serum
Non-Probability Sample
women in 1st trimester of pregnancy coming to clinique OVO for prenatal screening
Pregnancy
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study group
patients coming to clinique OVO in the 1st trimester of pregnancy to undergo prenatal screening
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
370
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01387776
B-PRN-10-01
No
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OVO R & D
OVO R & D
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Principal Investigator: Robert Hemmings, MD Clinique OVO
Study Director: Bernard Couturier, MD Clinique OVO
Study Chair: Dominique Berube, PhD Clinique OVO
OVO R & D
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP