PREDICTION2: Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening

Sponsor

Emmanuel Bujold (Other)

Overall Status

Completed

CT.gov ID

NCT03067298

Collaborator

Thermo Fisher Scientific, Inc (Industry), Laval University (Other)

805

Enrollment

Location

Actual Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia Preterm Birth Fetal Growth Restriction Intra Uterine Fetal Death

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.

Study Design

Study Type:

Observational

Actual Enrollment :

805 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jun 1, 2021

Outcome Measures

Primary Outcome Measures

preeclampsia [>20 weeks of 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

Secondary Outcome Measures

Fetal growth restriction [neonatal weight at birth (on the day of birth)]
defined as a birth weight below the 10th centile (or below the 3rd centile for severe FGR) of Canadian reference growth charts.
Preterm birth [between 20-37 weeks of gestation]
defined as delivery <37 weeks of gestation.
Intra uterine fetal death [from the 20th week of gestation to the moment of birth]
fetal death during pregnancy