Clinical trial NCT04631627: Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort
Official title: A Prospective Muti-center Study of Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Preeclampsia
Keywords: preeclampsia
aspirin
prediction
intervention
PAPP-A
PIGF
sFlt
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study intends to adopt the method of multi-center prospective randomized controlled study. The aim of this study is to obtain localized excision values through a preeclampsia screening model established in early pregnancy, and to evaluate the efficacy of low-dose aspirin intervention for preeclampsia prevention in pregnant women at high risk of screening.


Eligibility criteria: Inclusion Criteria:

* 1)Pregnant women assessed as at high risk of preeclampsia 2) live pregnancy 3) gestational weeks \< 16 weeks 4) agree to randomized drug intervention studies 5) follow up regularly and obtain reliable pregnancy outcomes

Exclusion Criteria:

* 1)with severe fetal or chromosomal abnormalities 2) induced labor or spontaneous abortion due to social factors 3) absolute or relative contraindications to aspirin use (allergy to aspirin or other salicylate, or other ingredients of the drug;Acute gastrointestinal ulcer;Active bleeding;In patients with severe G6PD deficiency, acetylsalicylic acid may induce hemolysis or hemolytic anemia.Aspirin asthma)

Primary outcomes:
measure: the rate of preeclampsia
timeFrame: through study completion, an average of 1 year
measure: the rate of hypertensive disorder during pregnancy
timeFrame: through study completion, an average of 1 year
measure: the rate of placenta abruption
timeFrame: through study completion, an average of 1 year
measure: the rate of fetal growth restriction
timeFrame: through study completion, an average of 1 year
measure: the rate of postpartum hemorrhage
timeFrame: within 24 hours after the delivery
measure: the time and type of delivery
timeFrame: within 24 hours after the delivery
Secondary outcomes:
measure: birth weight of newborn
timeFrame: delivery time
measure: Apgar score for newborns
timeFrame: delivery time
measure: the rate of Neonatal NICU occupancy rate
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.