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

March 14, 2022 updated by: Emmanuel Bujold

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

805

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Quebec, Canada, G1V 4G2
        • CHU de Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preeclampsia
Time Frame: >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
>20 weeks of preeclampsia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal growth restriction
Time Frame: 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.
neonatal weight at birth (on the day of birth)
Preterm birth
Time Frame: between 20-37 weeks of gestation
defined as delivery <37 weeks of gestation.
between 20-37 weeks of gestation
Intra uterine fetal death
Time Frame: from the 20th week of gestation to the moment of birth
fetal death during pregnancy
from the 20th week of gestation to the moment of birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

January 18, 2017

First Submitted That Met QC Criteria

February 23, 2017

First Posted (Actual)

March 1, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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