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Completed

NCT Number: NCT03554681

Prediction of Preeclampsia (PE) at 11-13 Week

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

First Affiliated Hospital of Kunming Medical University, Kunming, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

  1. The false positive and true positive frequencies for screening for PE using the Bayes theorem based methods

    Time frame: At delivery

Secondary outcomes

  1. 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

    Time frame: At delivery

Sponsors and collaborators

Lead sponsor

Chiu Yee Liona Poon

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jun 13, 2018
Registry last updated
Jan 2, 2020

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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