Study Results
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Basic Information
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COMPLETED
10935 participants
OBSERVATIONAL
2016-12-31
2019-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* Live fetus
* Provide Informed and written consent in the official language of the country
Exclusion Criteria
* Multiple Pregnancy
* Non-viable fetus (missed spontaneous abortion or stillbirth)
18 Years
FEMALE
No
Sponsors
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Chiu Yee Liona Poon
OTHER
Responsible Party
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Chiu Yee Liona Poon
Associate Professor (Clinical)
Principal Investigators
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Liona CY Poon
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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First Affiliated Hospital of Kunming Medical University
Kunming, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Kwong Wah Hospital
Hong Kong, , Hong Kong
Prince of Wales Hospital
Hong Kong, , Hong Kong
Mediscan Chennai
Chennai, Tamil Nadu, India
Toyama University Hospital
Toyama, Toyama, Japan
Clinical Research Institute of Fetal Medicine PMC
Osaka, , Japan
Affiliated hospitals within The Japan Society for the Study of Hypertension in Pregnancy (JSSHP)
Tokyo, , Japan
Showa University Hospital
Tokyo, , Japan
KK Women's and Children's Hospital
Singapore, , Singapore
National University Hospital
Singapore, , Singapore
Taipei Chang Gung Memorial Hospital
Taipei, , Taiwan
Chulalongkorn University Bangkok
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Countries
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References
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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/
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2016.152
Identifier Type: -
Identifier Source: org_study_id
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