Prediction of Preeclampsia (PE) at 11-13 Week

Study Overview
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Brief Summary
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This is an international multicentre prospective cohort study to validate the Bayes theorem based algorithms for the screening of pre-eclampsia (PE) in the first-trimester of pregnancy.

Detailed Description
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The investigators have previously constructed Bayes model in the first-trimester which combines maternal characteristics and medical history (Mat-CH) together with mean arterial pressure (MAP), uterine artery pulsatility index (PI), and serum placental growth factor (PlGF) with a plan to assess the predictive performance. The reference standards will be PE defined according to the International Society for the Study of Hypertension in Pregnancy and the American College of Obstetricians and Gynecologists. The systolic blood pressure should be >140 mm Hg and/or the diastolic blood pressure should be >90 mmHg on at least two occasions four hours apart developing after 20 weeks' gestation in previously normotensive women and there should be proteinuria (>300 mg in 24 hours or two readings of at >2+ on dipstick analysis of midstream or catheter urine specimens if no 24-hour collection is available). In the absence of proteinuria, new onset of any of the following systemic findings: a) thrombocytopaenia (platelet counts <100,000 µL); b) renal insufficiency (creatinine >1.1 mg/dL or 2-fold increase in creatinine in the absence of underlying renal disease); c) abnormal liver function (ie, hepatic transaminase levels twice normal); d) pulmonary oedema; or e) cerebral or visual symptoms. Preterm-PE is PE that requires delivery before 37 weeks' gestation. If a participant fulfills the criteria for PE by one definition and not the other she will be considered to have developed PE.

Official Title
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Prospective Validation of Prediction Algorithms for Preeclampsia in the First-trimester of Pregnancy

Conditions
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Pre-Eclampsia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 18 years Singleton pregnancy Live fetus Provide Informed and written consent in the official language of the country Exclusion Criteria: Unable to provide written Informed consent learning difficulties or serious mental illness or an inability to understand spoken and written the official language of the country. Multiple Pregnancy Non-viable fetus (missed spontaneous abortion or stillbirth)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The false positive and true positive frequencies for screening for PE using the Bayes theorem based methods |  | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The false positive and true positive frequencies for screening of delivery of all-Small for Gestational Age (SGA) neonates and preterm-SGA neonates (delivery before 37 weeks), with or without PE |  | At delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bayes Model