Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort

Preeclampsia Clinical Trial

Official title:

A Prospective Muti-center Study of Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04631627
• Other study ID #: EPRPLACC
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 16, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: November 2020
• Source: Peking Union Medical College Hospital
• Contact: Jinsong Gao, PhD
• Phone: 18601106857
• Email: gaojsong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: August 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

References & Publications (8)

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. Erratum in: Fetal Diagn Ther. 2013;34(1):43. — View Citation

American College of Obstetricians and Gynecologists; Task Force on Hypertension in Pregnancy. Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-31. doi: 10.1097/01.AOG.0000437382.03963.88. — View 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. Review. — View 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. — View 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. — View Citation

Say L, Chou D, Gemmill A, Tunçalp Ö, Moller AB, Daniels J, Gülmezoglu 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of preeclampsia	Hypertensive onset after 20 weeks of gestation is accompanied by proteinuria,or with thrombocytopenia, impaired liver function, renal insufficiency,pulmonary edema,headache without other explanation and so on.	through study completion, an average of 1 year
Primary	the rate of hypertensive disorder during pregnancy	gestational hypertension, preeclampsia, chronic hypertension with preeclampsia, eclampsia, HELLP syndrome	through study completion, an average of 1 year
Primary	the rate of placenta abruption	After 20 weeks of pregnancy, the placenta in its normal position is completely or partially removed from the uterine wall before delivery of the fetus	through study completion, an average of 1 year
Primary	the rate of fetal growth restriction	The birth weight of the fetus is below two standard deviations of the average weight for the same gestational age or below the 10th percentile of normal weight for the same age	through study completion, an average of 1 year
Primary	the rate of postpartum hemorrhage	Within 24 hours after the delivery of the fetus, the bleeding volume of vaginal delivery =500ml, cesarean delivery =1000ml	within 24 hours after the delivery
Primary	the time and type of delivery	gestational week, vaginal delivery and cesarean section	within 24 hours after the delivery
Secondary	birth weight of newborn	macrosomia, normal weight, low birth weight	delivery time
Secondary	Apgar score for newborns	=8;4-7,;=3	delivery time
Secondary	the rate of Neonatal NICU occupancy rate	the day of NICU occupancy	through study completion, an average of 1 year