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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01387776

Acronym

PlGF

Enrollment

370

Registered

2011-07-06

Start date

2012-06-30

Completion date

2015-06-30

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Canada

Outcome results