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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03067298
Other study ID # 2017-3219
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2016
Est. completion date June 2021

Study information

Verified date March 2022
Source CHU de Quebec-Universite Laval
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 805
Est. completion date June 2021
Est. primary completion date June 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - nulliparous pregnant women participating in Prediction study (NCT02189148) Exclusion Criteria: - <18 years old at recruitment; - multiple pregnancies; - fetal congenital malformation; - positive for HIV or hepatitis C; - fetal demise at recruitment; - women planning a delivery outside the participating hospitals; - women not able to provide an informed consent to the study.

Study Design


Locations

Country Name City State
Canada CHU de Quebec Quebec

Sponsors (3)

Lead Sponsor Collaborator
Emmanuel Bujold Laval University, Thermo Fisher Scientific

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 >20 weeks of preeclampsia
Secondary 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. neonatal weight at birth (on the day of birth)
Secondary Preterm birth defined as delivery <37 weeks of gestation. between 20-37 weeks of gestation
Secondary Intra uterine fetal death fetal death during pregnancy from the 20th week of gestation to the moment of birth
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