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

NCT04631627 | Unknown Phase 4

• 1 other identifier: EPRPLACC
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preeclampsia

Keywords

preeclampsia; aspirin; prediction; intervention; PAPP-A; PIGF; sFlt

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• the time and type of delivery

  gestational week, vaginal delivery and cesarean section

  within 24 hours after the delivery

Secondary Outcomes (3)

• birth weight of newborn

  delivery time

• Apgar score for newborns

  delivery time

• the rate of Neonatal NICU occupancy rate

  through study completion, an average of 1 year

Study Arms (2)

aspirin group

ACTIVE COMPARATOR

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.

Drug: Aspirin

control group

SHAM COMPARATOR

with no intervention

Drug: Aspirin

Interventions

Aspirin DRUG

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.

aspirin group; control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: gestational women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• )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

You may not qualify if:

• )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)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Related Publications (8)

• 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.

  PMID: 19464502 BACKGROUND

• 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.

  PMID: 25103301 BACKGROUND

• 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.

  PMID: 24150027 BACKGROUND

• 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.

  PMID: 22906914 BACKGROUND

• 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.

  PMID: 25678383 BACKGROUND

• 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.

  PMID: 29239588 BACKGROUND

• 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.

  PMID: 30710362 BACKGROUND

• 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.

  PMID: 30797761 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Jinsong Gao, PhD

CONTACT

18601106857; gaojsong@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2020
• First Posted: November 17, 2020
• Study Start: November 16, 2020
• Primary Completion: December 30, 2021
• Study Completion: August 30, 2022
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 31 June, 2022