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NCT Number: NCT03067298

Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening

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.

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Key information

Conditions

Preeclampsia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Restriction Fetal Growth Retardation Growth Disorders Hypertension, Pregnancy-Induced Intra Uterine Fetal Death Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Quebec

Québec, G1V 4G2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. preeclampsia

    Time frame: >20 weeks of preeclampsia

    • 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 outcomes

  1. 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.

  2. Preterm birth

    Time frame: between 20-37 weeks of gestation

    defined as delivery <37 weeks of gestation.

  3. Intra uterine fetal death

    Time frame: from the 20th week of gestation to the moment of birth

    fetal death during pregnancy

Sponsors and collaborators

Lead sponsor

Emmanuel Bujold

Other

Collaborators

  • Laval University
  • Thermo Fisher Scientific, Inc

Registry information

Acronym: PREDICTION2

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Mar 1, 2017
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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