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Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening

NCT03067298 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 805

Last updated 2022-03-15

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Thermo Fisher Scientific, Inc

    collaborator INDUSTRY

  • Laval University

    collaborator OTHER

  • Emmanuel Bujold

    lead OTHER

Principal Investigators

  • Emmanuel Bujold, MD, MSc · CHU de Quebec

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-06-30
Completion
2021-06-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03067298 on ClinicalTrials.gov