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

Pregnancy Clinical Trial

— PlGF  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01387776
• Other study ID #: B-PRN-10-01
• Status: Terminated
• Phase: N/A
• First received: January 31, 2011
• Last updated: July 24, 2015
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: OVO R & D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 370
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Pregnancy

Locations

Country	Name	City	State
Canada	OVO Prénatal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
OVO R & D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No