Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)
NCT ID: NCT03941886
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42454 participants
INTERVENTIONAL
2019-07-31
2023-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Non-intervention group
Participants receive routine prenatal care
No interventions assigned to this group
Intervention group
Participants receive first-trimester screening for preterm-preeclampsia by the Bayes based method followed by commencement of low-dose aspirin prophylaxis in high-risk women.
Low-dose aspirin in women with high risk of preeclampsia
Low-dose aspirin 150-162 mg/night or 100 mg/night if body weight \<40 Kg, from \<15 weeks till 36 weeks or, in the event of early delivery, at the onset of labor
Interventions
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Low-dose aspirin in women with high risk of preeclampsia
Low-dose aspirin 150-162 mg/night or 100 mg/night if body weight \<40 Kg, from \<15 weeks till 36 weeks or, in the event of early delivery, at the onset of labor
Eligibility Criteria
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Inclusion Criteria
* Live fetus;
Exclusion Criteria
* Major fetal defects identified at 11-13 weeks of assessment;
* 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
Professor (Clinical)
Principal Investigators
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Liona CY Poon, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Guangzhou Women and Children's Medical Center
Guangzhou, , China
Kunming Angel Women & Children Hospital
Kunming, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Prince of Wales Hospital
Hong Kong, Hong Kong, China, Hong Kong
Kwong Wah Hospital
Hong Kong, , Hong Kong
Harapan Kita Hospital
Jakarta, , Indonesia
Clinical Research Institute of Fetal Medicine
Osaka, , Japan
Showa University Hospital
Tokyo, , Japan
Japan Society for the Study of Hypertension in Pregnancy
Toyama, , Japan
Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre
Bandar Tun Razak, , Malaysia
Philippine General Hospital
Manila, , Philippines
National University Hospital
Singapore, , Singapore
Chang Gung Hospital
Taipei, , Taiwan
Taiji Clinic
Taipei, , Taiwan
Chulalongkorn University Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Thammasat University Hospital
Khlong Luang, , Thailand
Hanoi Obstetrics & Gynecology Hospital
Hanoi, , Vietnam
Countries
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References
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Geographic variation in the incidence of hypertension in pregnancy. World Health Organization International Collaborative Study of Hypertensive Disorders of Pregnancy. Am J Obstet Gynecol. 1988 Jan;158(1):80-3.
Steegers EA, von Dadelszen P, Duvekot JJ, Pijnenborg R. Pre-eclampsia. Lancet. 2010 Aug 21;376(9741):631-44. doi: 10.1016/S0140-6736(10)60279-6. Epub 2010 Jul 2.
Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9.
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.
Tranquilli AL, Dekker G, Magee L, Roberts J, Sibai BM, Steyn W, Zeeman GG, Brown MA. The classification, diagnosis and management of the hypertensive disorders of pregnancy: A revised statement from the ISSHP. Pregnancy Hypertens. 2014 Apr;4(2):97-104. doi: 10.1016/j.preghy.2014.02.001. Epub 2014 Feb 15. No abstract available.
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/
Committee Opinion No. 638: First-Trimester Risk Assessment for Early-Onset Preeclampsia. Obstet Gynecol. 2015 Sep;126(3):e25-e27. doi: 10.1097/AOG.0000000000001049.
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.
O'Gorman N, Wright D, Poon LC, Rolnik DL, Syngelaki A, de Alvarado M, Carbone IF, Dutemeyer V, Fiolna M, Frick A, Karagiotis N, Mastrodima S, de Paco Matallana C, Papaioannou G, Pazos A, Plasencia W, Nicolaides KH. Multicenter screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation: comparison with NICE guidelines and ACOG recommendations. Ultrasound Obstet Gynecol. 2017 Jun;49(6):756-760. doi: 10.1002/uog.17455.
Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.
Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402.
Poon LC, Zymeri NA, Zamprakou A, Syngelaki A, Nicolaides KH. Protocol for measurement of mean arterial pressure at 11-13 weeks' gestation. Fetal Diagn Ther. 2012;31(1):42-8. doi: 10.1159/000335366. Epub 2012 Jan 13.
Chen Y, Nguyen-Hoang L, Dinh LT, Nguyen DA, Pooh RK, Shiozaki A, Zheng M, Hu Y, Ma R, Kusuma A, Wataganara T, Choolani MA, Kaneko M, Luewan S, Chang TY, Chaiyasit N, Nanthakomon T, Jiang Y, Shaw SW, Leung WC, Mohamad AS, Aguilar A, Lau SL, Lee NMW, Liu J, Sahota DS, Chong MKC, Papastefanou I, Poon LC. Effect of aspirin on small for gestational age neonates in pregnancies at high-risk for preeclampsia: a secondary analysis of a cluster randomised clinical trial. Lancet Reg Health West Pac. 2025 Jun 5;59:101582. doi: 10.1016/j.lanwpc.2025.101582. eCollection 2025 Jun.
Nguyen-Hoang L, Dinh LT, Tai AST, Nguyen DA, Pooh RK, Shiozaki A, Zheng M, Hu Y, Li B, Kusuma A, Yapan P, Gosavi A, Kaneko M, Luewan S, Chang TY, Chaiyasit N, Nanthakomon T, Liu H, Shaw SW, Leung WC, Mahdy ZA, Aguilar A, Leung HHY, Lee NMW, Lau SL, Wah IYM, Lu X, Sahota DS, Chong MKC, Poon LC; FORECAST Collaborators. Implementation of First-Trimester Screening and Prevention of Preeclampsia: A Stepped Wedge Cluster-Randomized Trial in Asia. Circulation. 2024 Oct 15;150(16):1223-1235. doi: 10.1161/CIRCULATIONAHA.124.069907. Epub 2024 Jun 26.
Other Identifiers
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2018-0434
Identifier Type: -
Identifier Source: org_study_id