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The Effectiveness of Aspirin on Preventing Pre-eclampsia

Primary Purpose

Pre-Eclampsia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aspirin
Sponsored by
The Third Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-Eclampsia focused on measuring Pre-eclampsia, Aspirin

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    75mg

    100mg

    blank

    Arm Description

    Take 75mg of aspirin daily in tihis group

    Take 100mg of aspirin daily in this group

    Not taking aspirin in this group

    Outcomes

    Primary Outcome Measures

    Incidence of pre-eclampsia
    Record the number of pre-eclampsia in each group and compare whether there are statistical differences in the incidence of each group

    Secondary Outcome Measures

    Preterm birth
    Record the number of preterm in each group and compare whether there are statistical differences in the incidence of each group
    Fetal growth restriction
    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
    Record the number of placental abruption in each group and compare whether there are statistical differences in the incidence of each group
    Postpartum hemorrhage
    Record the number of postpartum hemorrhage in each group and compare whether there are statistical differences in the incidence of each group

    Full Information

    First Posted
    November 11, 2020
    Last Updated
    March 9, 2021
    Sponsor
    The Third Affiliated Hospital of Guangzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04656665
    Brief Title
    The Effectiveness of Aspirin on Preventing Pre-eclampsia
    Official Title
    The Effectiveness of Low-dose Aspirin on Preventing Pre-eclampsia in High-risks Pregnant Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 15, 2021 (Anticipated)
    Primary Completion Date
    December 14, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Third Affiliated Hospital of Guangzhou Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pre-Eclampsia
    Keywords
    Pre-eclampsia, Aspirin

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    75mg
    Arm Type
    Experimental
    Arm Description
    Take 75mg of aspirin daily in tihis group
    Arm Title
    100mg
    Arm Type
    Active Comparator
    Arm Description
    Take 100mg of aspirin daily in this group
    Arm Title
    blank
    Arm Type
    No Intervention
    Arm Description
    Not taking aspirin in this group
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin
    Other Intervention Name(s)
    Acetylsalicylic acid
    Intervention Description
    For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy
    Primary Outcome Measure Information:
    Title
    Incidence of pre-eclampsia
    Description
    Record the number of pre-eclampsia in each group and compare whether there are statistical differences in the incidence of each group
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Preterm birth
    Description
    Record the number of preterm in each group and compare whether there are statistical differences in the incidence of each group
    Time Frame
    1 year
    Title
    Fetal growth restriction
    Description
    Record the number of FGR in each group and compare whether there are statistical differences in the incidence of each group
    Time Frame
    1 year
    Title
    Placental abruption 4/5000 Placental abruption
    Description
    Record the number of placental abruption in each group and compare whether there are statistical differences in the incidence of each group
    Time Frame
    1 year
    Title
    Postpartum hemorrhage
    Description
    Record the number of postpartum hemorrhage in each group and compare whether there are statistical differences in the incidence of each group
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fang He, Dr.
    Phone
    +86020-81292532
    Email
    hefangjnu@126.com

    12. IPD Sharing Statement

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    The Effectiveness of Aspirin on Preventing Pre-eclampsia

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