An observational study in Preeclampsia, Preterm Birth and Fetal Growth Restriction, sponsored by Emmanuel Bujold. Completed at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Emmanuel Bujold · Observational
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.
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.
904 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.
This study's enrollment of 805 is above the median of 160 across 389 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →This is the only study on the registry with Emmanuel Bujold as lead sponsor.
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Pregnant women
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Exclusion Criteria:
preeclampsia
1\) de novo hypertension with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure \>90 mmHg on two occasions at least four hours apart, after 20 weeks of pregnancy, and 2) associated with proteinuria ≥300 mg/24 h or at least '2 +' protein on urine dipstick or an adverse conditions
Time frame: >20 weeks of preeclampsia
Fetal growth restriction
defined as a birth weight below the 10th centile (or below the 3rd centile for severe FGR) of Canadian reference growth charts.
Time frame: neonatal weight at birth (on the day of birth)
Preterm birth
defined as delivery \<37 weeks of gestation.
Time frame: between 20-37 weeks of gestation
Intra uterine fetal death
fetal death during pregnancy
Time frame: from the 20th week of gestation to the moment of birth
Plan to share: No
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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