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Pre-EclampsiaNCT03554681

Prediction of Preeclampsia (PE) at 11-13 Week

An observational study of Pre-Eclampsia, run by Chiu Yee Liona Poon at 14 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pre-Eclampsia
How many people
10,935 participants
Where
14 sitesin 7 countries
Study dates
Dec 2016to Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Aged ≥ 18 years
  • Singleton pregnancy
  • Live fetus
  • Provide Informed and written consent in the official language of the country

Who cannot join

  • 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)

Trial locations and contacts

14 sites in 7 countries.

14 sites in 7 countries

Japan4 sites

  • Clinical Research Institute of Fetal Medicine PMC

    Osaka

  • Affiliated hospitals within The Japan Society for the Study of Hypertension in Pregnancy (JSSHP)

    Tokyo

  • Showa University Hospital

    Tokyo

  • Toyama University Hospital

    Toyama, Toyama

Other trials in Japan

China2 sites

  • First Affiliated Hospital of Kunming Medical University

    Kunming

  • Nanjing Drum Tower Hospital

    Nanjing

Other trials in China

Hong Kong2 sites

  • Kwong Wah Hospital

    Hong Kong

  • Prince of Wales Hospital

    Hong Kong

Other trials in Hong Kong

Singapore2 sites

  • KK Women's and Children's Hospital

    Singapore

  • National University Hospital

    Singapore

Other trials in Singapore

Thailand2 sites

  • Chulalongkorn University Bangkok

    Bangkok

  • Siriraj Hospital

    Bangkok

Other trials in Thailand

India1 site

  • Mediscan Chennai

    Chennai, Tamil Nadu

Other trials in India

Taiwan1 site

  • Taipei Chang Gung Memorial Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Conditions
Pre-Eclampsia
Keywords
Bayes Model
Medical subject headings
Pre-Eclampsia

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At delivery

Secondary outcomes (1)

  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

    Measured: At delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2018
  2. Study startDec 2016
  3. Primary completionDec 2018
  4. Study completionSep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,935 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03554681
Sponsor's protocol ID
2016.152
Status last verified
Dec 2019
First submitted
9 May 2018
Last updated
2 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • National Collaborating Centre for Women's and Children's Health (UK). Hypertension in Pregnancy: The Management of Hypertensive Disorders During Pregnancy. London: RCOG Press; 2010 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK62652/

    PubMed 22220321

  • Askie LM, Duley L, Henderson-Smart DJ, Stewart LA; PARIS Collaborative Group. Antiplatelet agents for prevention of pre-eclampsia: a meta-analysis of individual patient data. Lancet. 2007 May 26;369(9575):1791-1798. doi: 10.1016/S0140-6736(07)60712-0.

    PubMed 17512048

  • Bujold E, Roberge S, Lacasse Y, Bureau M, Audibert F, Marcoux S, Forest JC, Giguere Y. Prevention of preeclampsia and intrauterine growth restriction with aspirin started in early pregnancy: a meta-analysis. Obstet Gynecol. 2010 Aug;116(2 Pt 1):402-414. doi: 10.1097/AOG.0b013e3181e9322a.

    PubMed 20664402

  • Roberge S, Villa P, Nicolaides K, Giguere Y, Vainio M, Bakthi A, Ebrashy A, Bujold E. Early administration of low-dose aspirin for the prevention of preterm and term preeclampsia: a systematic review and meta-analysis. Fetal Diagn Ther. 2012;31(3):141-6. doi: 10.1159/000336662. Epub 2012 Mar 21.

    PubMed 22441437

  • Roberge S, Giguere Y, Villa P, Nicolaides K, Vainio M, Forest JC, von Dadelszen P, Vaiman D, Tapp S, Bujold E. Early administration of low-dose aspirin for the prevention of severe and mild preeclampsia: a systematic review and meta-analysis. Am J Perinatol. 2012 Aug;29(7):551-6. doi: 10.1055/s-0032-1310527. Epub 2012 Apr 11.

    PubMed 22495898

  • Wright D, Syngelaki A, Akolekar R, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal characteristics and medical history. Am J Obstet Gynecol. 2015 Jul;213(1):62.e1-62.e10. doi: 10.1016/j.ajog.2015.02.018. Epub 2015 Feb 25.

    PubMed 25724400

  • O'Gorman N, Wright D, Syngelaki A, Akolekar R, Wright A, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal factors and biomarkers at 11-13 weeks gestation. Am J Obstet Gynecol. 2016 Jan;214(1):103.e1-103.e12. doi: 10.1016/j.ajog.2015.08.034. Epub 2015 Aug 19.

    PubMed 26297382

  • Gallo DM, Wright D, Casanova C, Campanero M, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal factors and biomarkers at 19-24 weeks' gestation. Am J Obstet Gynecol. 2016 May;214(5):619.e1-619.e17. doi: 10.1016/j.ajog.2015.11.016. Epub 2015 Nov 25.

    PubMed 26627730

  • Tsiakkas A, Saiid Y, Wright A, Wright D, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal factors and biomarkers at 30-34 weeks' gestation. Am J Obstet Gynecol. 2016 Jul;215(1):87.e1-87.e17. doi: 10.1016/j.ajog.2016.02.016. Epub 2016 Feb 12.

    PubMed 26875953

  • Andrietti S, Silva M, Wright A, Wright D, Nicolaides KH. Competing-risks model in screening for pre-eclampsia by maternal factors and biomarkers at 35-37 weeks' gestation. Ultrasound Obstet Gynecol. 2016 Jul;48(1):72-9. doi: 10.1002/uog.15812. Epub 2016 May 30.

    PubMed 26566592

  • Brown MA, Lindheimer MD, de Swiet M, Van Assche A, Moutquin JM. The classification and diagnosis of the hypertensive disorders of pregnancy: statement from the International Society for the Study of Hypertension in Pregnancy (ISSHP). Hypertens Pregnancy. 2001;20(1):IX-XIV. doi: 10.1081/PRG-100104165. No abstract available.

    PubMed 12044323

  • Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.

    PubMed 24150027

  • Snijders RJ, Nicolaides KH. Fetal biometry at 14-40 weeks' gestation. Ultrasound Obstet Gynecol. 1994 Jan 1;4(1):34-48. doi: 10.1046/j.1469-0705.1994.04010034.x.

    PubMed 12797224

  • Acharya G, Wilsgaard T, Berntsen GK, Maltau JM, Kiserud T. Reference ranges for serial measurements of umbilical artery Doppler indices in the second half of pregnancy. Am J Obstet Gynecol. 2005 Mar;192(3):937-44. doi: 10.1016/j.ajog.2004.09.019.

    PubMed 15746695

  • Vyas S, Campbell S, Bower S, Nicolaides KH. Maternal abdominal pressure alters fetal cerebral blood flow. Br J Obstet Gynaecol. 1990 Aug;97(8):740-2. doi: 10.1111/j.1471-0528.1990.tb16250.x. No abstract available.

    PubMed 2205291

Questions about this trial

What is this clinical trial studying?

An observational study of Pre-Eclampsia, run by Chiu Yee Liona Poon at 14 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Japan, China, Hong Kong, Singapore, Thailand and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The false positive and true positive frequencies for screening for PE using the Bayes theorem based methods (time frame: At delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03554681, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.

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