NCT02879942

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

First-trimester Study of the Morphometric Characteristics of the Placenta to Assess the Risk of Preeclampsia and Intrauterine Growth Restriction in Singleton Pregnancies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,390 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: Female
• Age: 11 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Preeclampsia
• Intrauterine Growth Restriction

Interventions

Type	Name	Description
OTHER	Ultrasound study of the placenta	The placenta will be scanned to measure the placental volume, chorionic plate, basal plate and thickness.
OTHER	Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test

Timeline

• Start date: 2016-08-01
• Primary completion: 2020-02-01
• Completion: 2020-07-01
• First posted: 2016-08-26
• Last updated: 2022-03-09

Locations

1 site across 1 country: Spain