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

F

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

Status

Completed

Conditions

Preeclampsia
Intrauterine Growth Restriction

Treatments

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

Study type

Observational

Funder types

Other
NETWORK

Identifiers

NCT02879942
IIBSP-PLA-2016-31

Details and patient eligibility

About

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.

Enrollment

1,390 patients

Sex

Female

Ages

11 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

1,390 participants in 2 patient groups

Case cohort
Description:
Patients with pregnancies complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort.
Treatment:
Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test
Other: Ultrasound study of the placenta
Control cohort
Description:
Patients with pregnancies not complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort.
Treatment:
Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test
Other: Ultrasound study of the placenta

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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