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

Study Overview
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Brief Summary
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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.

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

Conditions
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Preeclampsia, Intrauterine Growth Restriction

Intervention / Treatment
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* Other: Ultrasound study of the placenta
* Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case cohort<br>Patients with pregnancies complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort. | Other: Ultrasound study of the placenta<br>* The placenta will be scanned to measure the placental volume, chorionic plate, basal plate and thickness.<br>Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test<br> <br> |
| Control cohort<br>Patients with pregnancies not complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort. | Other: Ultrasound study of the placenta<br>* The placenta will be scanned to measure the placental volume, chorionic plate, basal plate and thickness.<br>Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Development of intrauterine growth restriction | Intrauterine growth restriction is defined as birthweight below 10th centile according to local standards | At birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Placental volume, First-trimester screening, Ultrasound, Preeclampsia, Intrauterine growth restriction, Biochemical markers, Uterine artery doppler