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

Ovo Clinic

Status: Terminated

Conditions: Pregnancy

Study type: Observational

Funder types: Industry

Identifiers

NCT01387776

B-PRN-10-01

Details and patient eligibility

About

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.

Enrollment: 370 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

370 participants in 1 patient group

study group

Description:

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