Prediction of Preeclampsia (PE) at 11-13 Week

December 31, 2019 updated by: Chiu Yee Liona Poon

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

10935

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

  • China
      • Kunming, China
        • First Affiliated Hospital of Kunming Medical University
      • Nanjing, China
        • Nanjing Drum Tower Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
      • Hong Kong, Hong Kong
        • Kwong Wah Hospital
  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Mediscan Chennai
  • Japan
      • Osaka, Japan
        • Clinical Research Institute of Fetal Medicine PMC
      • Tokyo, Japan
        • Showa University Hospital
      • Tokyo, Japan
        • Affiliated hospitals within The Japan Society for the Study of Hypertension in Pregnancy (JSSHP)
    • Toyama Prefecture
      • Toyama, Toyama Prefecture, Japan
        • Toyama University Hospital
  • Singapore
      • Singapore, Singapore
        • National University Hospital
      • Singapore, Singapore
        • KK Women's and Children's Hospital
  • Taiwan
      • Taipei, Taiwan
        • Taipei Chang Gung Memorial Hospital
  • Thailand
      • Bangkok, Thailand
        • Siriraj Hospital
      • Bangkok, Thailand
        • Chulalongkorn University Bangkok

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

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All eligible women attending for their hospital visit at 11-13 weeks will be invited to participate.

Description

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)

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
Time Frame
The false positive and true positive frequencies for screening for PE using the Bayes theorem based methods
Time Frame: At delivery
At delivery

Secondary Outcome Measures

Outcome Measure
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
Time Frame: At delivery
At delivery

Collaborators and Investigators

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

Sponsor

Chiu Yee Liona Poon

Investigators

  • Principal Investigator: Liona CY Poon, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

May 9, 2018

First Submitted That Met QC Criteria

June 3, 2018

First Posted (Actual)

June 13, 2018

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016.152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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