First-trimester Study of the Morphometric Characteristics of the Placenta to Assess the Risk of Preeclampsia and Intrauterine Growth Restriction in Singleton Pregnancies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,390
- Locations
- 1
- Primary Endpoint
- Development of preeclampsia
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 11 Years to 60 Years (Child, Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
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
Development of intrauterine growth restriction
Time Frame: At birth
Intrauterine growth restriction is defined as birthweight below 10th centile according to local standards
Secondary Outcomes
No secondary outcomes reported