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

Completed

• Conditions: Preeclampsia; Intrauterine Growth Restriction
• Interventions: Other: Ultrasound study of the placenta; Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test

• Registration Number: NCT02879942
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-20
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-26
• Primary Completion: 2020-02
• Study Completion: 2020-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1390

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case cohort	Ultrasound study of the placenta	Patients with pregnancies complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort.
Control cohort	Ultrasound study of the placenta	Patients with pregnancies not complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort.
Case cohort	Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test	Patients with pregnancies complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort.
Control cohort	Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test	Patients with pregnancies not complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort.

Primary Outcome Measures

Name	Time	Method
Development of preeclampsia	Up to birth	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
Development of intrauterine growth restriction	At birth	Intrauterine growth restriction is defined as birthweight below 10th centile according to local standards

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain