First Trimester Placental Assessment in the Screening of Preeclampsia and Intrauterine Growth Restriction

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Completed

Conditions: Preeclampsia; Intrauterine Growth Restriction

Treatments: Other: Ultrasound study of the placenta; Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT02879942

IIBSP-PLA-2016-31

Details and patient eligibility

About

Preeclampsia (PE) and intrauterine growth restriction (IUGR) are clinical manifestations of placental insufficiency. These complications affect 5-15% of pregnancies, and are responsible for up to 20% of preterm births. Women who develop PE during pregnancy also have an increased risk for cardiovascular events, both at short and long term. This justifies the need to improve diagnostic tools to identify patients at risk for these complications. PE and IUGR are multifactorial entities. Screening algorithms should thus include several parameters to achieve high detection rates. Research has mainly focused in the analysis of biophysical and biochemical parameters, and the study of the placenta itself has not been included in current diagnostic strategies. Investigators hypothesize that detection rates of preeclampsia and intrauterine growth restriction could be improved by the study of placental characteristics in the first trimester of pregnancy.

Enrollment: 1,390 patients

Sex: Female

Ages: 11 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pregnancies with fetuses with CRL between 45 and 80mm
• absence of chromosomal abnormalities
• absence of congenital anomalies
• absence of congenital infections

Exclusion criteria

• patient not accepting to participate in the study
• multiple pregnancies
• pregnancies without ultrasonographic confirmation of gestational age

Trial design

1,390 participants in 2 patient groups

Case cohort

Description:

Patients with pregnancies complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort.

Treatment:

Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test

Other: Ultrasound study of the placenta

Control cohort

Description:

Patients with pregnancies not complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort.

Treatment:

Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test

Other: Ultrasound study of the placenta