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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-07-31

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.

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Detailed Description

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Conditions

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Preeclampsia Intrauterine Growth Restriction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Case cohort

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

Ultrasound study of the placenta

Intervention Type OTHER

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

Intervention Type OTHER

Control cohort

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

Ultrasound study of the placenta

Intervention Type OTHER

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

Intervention Type OTHER

Interventions

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Ultrasound study of the placenta

The placenta will be scanned to measure the placental volume, chorionic plate, basal plate and thickness.

Intervention Type OTHER

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

Intervention Type OTHER

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