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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02879942
Enrollment
1390
Registered
2016-08-26
Start date
2016-08-31
Completion date
2020-07-31
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Growth Restriction, Preeclampsia

Keywords

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

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.

Interventions

OTHERUltrasound study of the placenta

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

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

Sponsors

Spanish Clinical Research Network - SCReN
CollaboratorNETWORK
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
11 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Development of preeclampsiaUp to birthPre-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
Development of intrauterine growth restrictionAt birthIntrauterine growth restriction is defined as birthweight below 10th centile according to local standards

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026