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

NCT01387776 | Terminated

• 1 other identifier: B-PRN-10-01
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

study group

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Ovo: lead

Study Sites (1)

OVO Prénatal

Montreal, Quebec, H4P2S4, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Study Officials

• Robert Hemmings, MD

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

• Bernard Couturier, MD

  Clinique Ovo

  STUDY DIRECTOR

• Dominique Berube, PhD

  Clinique Ovo

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: July 6, 2011
• Study Start: June 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

CA (1)