The Effectiveness of Aspirin on Preventing Pre-eclampsia

Overview

This study will explore the effectiveness of low-dose aspirin on preventing pre-eclampsia in high-risks pregnant women by comparing the incidence of pre-eclampsia and pregnancy outcomes.

Full Title of Study: “The Effectiveness of Low-dose Aspirin on Preventing Pre-eclampsia in High-risks Pregnant Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Care Provider, Investigator)
  • Study Primary Completion Date: December 14, 2022

Detailed Description

Currently,low-dose aspirin is a commonly used drug to prevent pre-eclampsia. Many guidelines recommend starting low-dose aspirin in early pregnancy in high-risks pregnant women. However, the applicable population and use method of aspirin are still controversial in clinical practice. This study will explore the effectiveness and use method of low-dose aspirin by comparing the incidence of pre-eclampsia and pregnancy outcomes.

Interventions

  • Drug: Aspirin
    • For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy

Arms, Groups and Cohorts

  • Experimental: 75mg
    • Take 75mg of aspirin daily in tihis group
  • Active Comparator: 100mg
    • Take 100mg of aspirin daily in this group
  • No Intervention: blank
    • Not taking aspirin in this group

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of pre-eclampsia
    • Time Frame: 1 year
    • Record the number of pre-eclampsia in each group and compare whether there are statistical differences in the incidence of each group

Secondary Measures

  • Preterm birth
    • Time Frame: 1 year
    • Record the number of preterm in each group and compare whether there are statistical differences in the incidence of each group
  • Fetal growth restriction
    • Time Frame: 1 year
    • Record the number of FGR in each group and compare whether there are statistical differences in the incidence of each group
  • Placental abruption 4/5000 Placental abruption
    • Time Frame: 1 year
    • Record the number of placental abruption in each group and compare whether there are statistical differences in the incidence of each group
  • Postpartum hemorrhage
    • Time Frame: 1 year
    • Record the number of postpartum hemorrhage in each group and compare whether there are statistical differences in the incidence of each group

Participating in This Clinical Trial

Inclusion Criteria

  • Age between 18-55 years – Gestational age between 12-20 weeks of pregnancy – High risk of developing pre-eclampsia – At least one of the following risk factors: Pre-eclampsia in a previous pregnancy , Multiple pregnancy,Diabetes Mellitus(Type 1 or 2), Chronic Hypertension,Renal disease, Autoimmune disease. – At least two of the following risk factors: Primiparity,Pre-pregnancy Body Mass Index ≥28kg/m2, Age ≥35 years, Family members have a history of pre-eclampsia. – Maternal informed conset obtained Exclusion Criteria:

  • Contraindication to aspirin therapy (including but not limited to allergy and high bleeding risk) – Patient with known intention to terminate pregnancy – Fetal abnormalities detected (including but not limited to major fetal malformation and FGR) – Severe heart, liver, renal disease who can not burden the experiment – Alcohol and drug abuse – Being in another drug experiment within 3 months

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Third Affiliated Hospital of Guangzhou Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Fang He, Dr., +86020-81292532, hefangjnu@126.com

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