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

NCT02879942 | Completed

• 1 other identifier: IIBSP-PLA-2016-31
• Study Type: observational
• Target: 1,390
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Intrauterine Growth Restriction

Keywords

Placental volume; First-trimester screening; Ultrasound; Preeclampsia; Intrauterine growth restriction; Biochemical markers; Uterine artery doppler

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Interventions

Ultrasound study of the placenta OTHER

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

Case cohort; Control cohort

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

Case cohort; Control cohort

Eligibility Criteria

• Age: 11 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• pregnancies with fetuses with CRL between 45 and 80mm
• absence of chromosomal abnormalities
• absence of congenital anomalies
• absence of congenital infections

You may not qualify if:

• patient not accepting to participate in the study
• multiple pregnancies
• pregnancies without ultrasonographic confirmation of gestational age

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Spanish Clinical Research Network - SCReN: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples from the first blood test performed during pregnancy

MeSH Terms

Conditions

Pre-Eclampsia; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristina Trilla, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: July 1, 2020
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

ES (1)