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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879942
• Other study ID #: IIBSP-PLA-2016-31
• Status: Completed
• Start date: August 2016
• Est. completion date: July 2020

Study information

• Verified date: March 2022
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1390
• Est. completion date: July 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction
• Pre-Eclampsia
• Preeclampsia

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Spanish Clinical Research Network - SCReN

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of preeclampsia	Pre-eclampsia is diagnosed after 20 week of gestation with systolic blood pressure equal to or greater than 140 mmHg, diastolic blood pressure equal to or greater than 90 mmHg and proteinuria greater than or equal 0.3 g/d by 24 hour urine collection	Up to birth
Primary	Development of intrauterine growth restriction	Intrauterine growth restriction is defined as birthweight below 10th centile according to local standards	At birth