Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort
NCT ID: NCT04631627
Last Updated: 2020-11-17
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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UNKNOWN
PHASE4
1500 participants
INTERVENTIONAL
2020-11-16
2022-08-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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aspirin group
aspirin,tablet,100/150mg per day,(BMI\<30 100mg/d，BMI≥30 150mg/d)，from pregnancy weeks\<16 to 35 weeks or the day of delivery.
Aspirin
With the result of risk assessment for high risk and the risk of pregnant women, with each research center stratified random aspirin drug intervention, for each center screening high-risk and accord with the standard drug intervention study phase into eliminate pregnant women by using stochastic indicator 1:1 randomly into low-dose aspirin to prevent group and observation group, for each center in screening for risk and comply with the drug intervention study phase into the exclusion standard 1:1 by random indicator method pregnant women randomly into low-dose aspirin to prevent group and observation group.
control group
with no intervention
Aspirin
With the result of risk assessment for high risk and the risk of pregnant women, with each research center stratified random aspirin drug intervention, for each center screening high-risk and accord with the standard drug intervention study phase into eliminate pregnant women by using stochastic indicator 1:1 randomly into low-dose aspirin to prevent group and observation group, for each center in screening for risk and comply with the drug intervention study phase into the exclusion standard 1:1 by random indicator method pregnant women randomly into low-dose aspirin to prevent group and observation group.
Interventions
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Aspirin
With the result of risk assessment for high risk and the risk of pregnant women, with each research center stratified random aspirin drug intervention, for each center screening high-risk and accord with the standard drug intervention study phase into eliminate pregnant women by using stochastic indicator 1:1 randomly into low-dose aspirin to prevent group and observation group, for each center in screening for risk and comply with the drug intervention study phase into the exclusion standard 1:1 by random indicator method pregnant women randomly into low-dose aspirin to prevent group and observation group.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Central Contacts
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References
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Duley L. The global impact of pre-eclampsia and eclampsia. Semin Perinatol. 2009 Jun;33(3):130-7. doi: 10.1053/j.semperi.2009.02.010.
Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
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.
Akolekar R, Syngelaki A, Poon L, Wright D, Nicolaides KH. Competing risks model in early screening for preeclampsia by biophysical and biochemical markers. Fetal Diagn Ther. 2013;33(1):8-15. doi: 10.1159/000341264. Epub 2012 Aug 16.
Park F, Russo K, Williams P, Pelosi M, Puddephatt R, Walter M, Leung C, Saaid R, Rawashdeh H, Ogle R, Hyett J. Prediction and prevention of early-onset pre-eclampsia: impact of aspirin after first-trimester screening. Ultrasound Obstet Gynecol. 2015 Oct;46(4):419-23. doi: 10.1002/uog.14819. Epub 2015 Aug 31.
Sentilhes L, Azria E, Schmitz T. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Dec 14;377(24):2399-400. doi: 10.1056/NEJMc1713798. No abstract available.
FIGO Working Group on Good Clinical Practice in Maternal-Fetal Medicine. Good clinical practice advice: First trimester screening and prevention of pre-eclampsia in singleton pregnancy. Int J Gynaecol Obstet. 2019 Mar;144(3):325-329. doi: 10.1002/ijgo.12741. No abstract available.
Wright D, Nicolaides KH. Aspirin delays the development of preeclampsia. Am J Obstet Gynecol. 2019 Jun;220(6):580.e1-580.e6. doi: 10.1016/j.ajog.2019.02.034. Epub 2019 Feb 21.
Other Identifiers
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EPRPLACC
Identifier Type: -
Identifier Source: org_study_id