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

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ClinicalTrials.gov Identifier: NCT02879942
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : August 18, 2020
Sponsor:
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Preeclampsia Intrauterine Growth Restriction Other: Ultrasound study of the placenta Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test

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Study Type : Observational
Estimated Enrollment : 1250 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : August 2016
Actual Primary Completion Date : February 2020
Actual Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. Development of intrauterine growth restriction [ Time Frame: At birth ]
    Intrauterine growth restriction is defined as birthweight below 10th centile according to local standards


Biospecimen Retention:   Samples Without DNA
Serum samples from the first blood test performed during pregnancy


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Ages Eligible for Study:   11 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with singleton pregnancies and ultrasonographic evaluation between 11+0 and 13+6 weeks of gestation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879942


Locations
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Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08026
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Spanish Clinical Research Network - CAIBER
Investigators
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Principal Investigator: Cristina Trilla, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02879942    
Other Study ID Numbers: IIBSP-PLA-2016-31
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Placental volume
First-trimester screening
Ultrasound
Preeclampsia
Intrauterine growth restriction
Biochemical markers
Uterine artery doppler
Additional relevant MeSH terms:
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Pre-Eclampsia
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Angiogenesis Inhibitors
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents