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

Terminated

• Conditions: Pregnancy

• Registration Number: NCT01387776
• Lead Sponsor: Clinique Ovo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-07-05
• Study First Posted: 2011-07-06
• Study Start: 2012-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-24
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 370

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
levels of Placental Protein 13 (PP13) , PIGF, PAPP-A, PIBF	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

Trial Locations

Locations (1)

OVO Prénatal; 🇨🇦 Montreal, Quebec, Canada