Prediction of Preeclampsia (PE) at 11-13 Week

NCT03554681 | Completed

• 1 other identifier: 2016.152
• Study Type: observational
• Target: 10,935
• Locations: 7 countries
• Sites: 14

Brief 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.

Conditions

Pre-Eclampsia

Keywords

Bayes Model

Outcome Measures

Primary Outcomes (1)

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

  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

  At delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chiu Yee Liona Poon: lead

Study Sites (14)

First Affiliated Hospital of Kunming Medical University

Kunming, China

Location

Nanjing Drum Tower Hospital

Nanjing, China

Location

Kwong Wah Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Mediscan Chennai

Chennai, Tamil Nadu, India

Location

Toyama University Hospital

Toyama, Toyama, Japan

Location

Clinical Research Institute of Fetal Medicine PMC

Osaka, Japan

Location

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

Tokyo, Japan

Location

Showa University Hospital

Tokyo, Japan

Location

KK Women's and Children's Hospital

Singapore, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Taipei Chang Gung Memorial Hospital

Taipei, Taiwan

Location

Chulalongkorn University Bangkok

Bangkok, Thailand

Location

Siriraj Hospital

Bangkok, Thailand

Location

Related Publications (15)

• 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/

  PMID: 22220321 BACKGROUND

• 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.

  PMID: 17512048 BACKGROUND

• 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.

  PMID: 20664402 BACKGROUND

• 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.

  PMID: 22441437 BACKGROUND

• 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.

  PMID: 22495898 BACKGROUND

• 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.

  PMID: 25724400 BACKGROUND

• 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.

  PMID: 26297382 BACKGROUND

• 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.

  PMID: 26627730 BACKGROUND

• 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.

  PMID: 26875953 BACKGROUND

• 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.

  PMID: 26566592 BACKGROUND

• 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.

  PMID: 12044323 BACKGROUND

• 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.

  PMID: 24150027 BACKGROUND

• 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.

  PMID: 12797224 BACKGROUND

• 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.

  PMID: 15746695 BACKGROUND

• 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.

  PMID: 2205291 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

An additional blood 5ml sample, if agreed to by the study participant, for recovery of plasma for future research will be taken and archived at -80℃.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Liona CY Poon

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor (Clinical)

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 13, 2018
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: September 1, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2); IN (1); CN (2); SG (2); TW (1); TH (2); JP (4)