NCT03067298

Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 805 (actual)
• Sponsor: Emmanuel Bujold · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are called "Great Obstetrical Syndromes". Algorithms to predict those outcomes have been developed by combining maternal characteristics (history, age, BMI, blood pressure), biochemical (sFlt-1, β-hCG, PlGF, AFP) and sonographic (uterine artery Doppler, 3D of placenta, cervical length, nasal bone measurement, nuchal translucency) markers. Another prospective observational study ("PREDICTION study" NCT 02189148) is also ongoing, which aims to validate those algorithms at the first trimester of pregnancy. Recent data suggest that repeating the same measurements later in pregnancy could improve the detection rates, allowing closer monitoring of high-risk patients and potential therapeutics under investigation. The current study (PREDICTION2) is an ancillary study of PREDICTION and aims at validating the use of these markers in a combined iterative manner in the prediction of preeclampsia and other obstetrical outcomes.

Detailed description

The objective of this study is to validate the predictive values of biophysical (maternal blood pressure); biochemical (sFlt-1, β-hCG, PlGF, and AFP) and ultrasonographic (cervical length, Doppler, 3D evaluation of the placenta, 3D nasal bone) biomarkers at several timepoints for the prediction of adverse pregnancy outcomes including preterm birth, preeclampsia, fetal growth restriction and intra-uterine fetal death. These biomarkers will be evaluated at 14-16 weeks, 20-24 weeks and 30-34 weeks. Those specific gestational ages have been selected because they correspond to the typical clinical/hospital visits for prenatal blood and/or ultrasound screening.

Conditions

• Preeclampsia
• Preterm Birth
• Fetal Growth Restriction
• Intra Uterine Fetal Death

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-06-01
• Completion: 2021-06-01
• First posted: 2017-03-01
• Last updated: 2022-03-15

Locations

1 site across 1 country: Canada