Clinical trial NCT03067298: Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening
Official title: Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Preterm Birth
Fetal Growth Restriction
Intra Uterine Fetal Death
Keywords: pregnancy
screening
doppler
markers
PlGF
sFlt-1
placenta
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Thermo Fisher Scientific, Inc
name: Laval University
First posted: 2017-03-01
Enrollment: 805
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: preeclampsia
timeFrame: >20 weeks of preeclampsia
Secondary outcomes:
measure: Fetal growth restriction
timeFrame: neonatal weight at birth (on the day of birth)
measure: Preterm birth
timeFrame: between 20-37 weeks of gestation
measure: Intra uterine fetal death
timeFrame: from the 20th week of gestation to the moment of birth
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: CHU de Quebec
Study officials:
affiliation: CHU de Quebec
name: Emmanuel Bujold, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: