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

March 8, 2022 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08026
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with singleton pregnancies and ultrasonographic evaluation between 11+0 and 13+6 weeks of gestation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case cohort
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
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
Control cohort
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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators

Spanish Clinical Research Network - SCReN

Investigators

  • Principal Investigator: Cristina Trilla, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

July 1, 2020

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (ESTIMATE)

August 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-PLA-2016-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preeclampsia

Clinical Trials on Ultrasound study of the placenta

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe