The Effectiveness of Aspirin on Preventing Pre-eclampsia

Sponsor
The Third Affiliated Hospital of Guangzhou Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04656665
Collaborator
(none)
600
3
21.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
The Effectiveness of Low-dose Aspirin on Preventing Pre-eclampsia in High-risks Pregnant Women
Anticipated Study Start Date :
Mar 15, 2021
Anticipated Primary Completion Date :
Dec 14, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 75mg

Take 75mg of aspirin daily in tihis group

Drug: Aspirin
For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy
Other Names:
  • Acetylsalicylic acid
  • Active Comparator: 100mg

    Take 100mg of aspirin daily in this group

    Drug: Aspirin
    For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy
    Other Names:
  • Acetylsalicylic acid
  • No Intervention: blank

    Not taking aspirin in this group

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of pre-eclampsia [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 Outcome Measures

    1. Preterm birth [1 year]

      Record the number of preterm in each group and compare whether there are statistical differences in the incidence of each group

    2. Fetal growth restriction [1 year]

      Record the number of FGR in each group and compare whether there are statistical differences in the incidence of each group

    3. Placental abruption 4/5000 Placental abruption [1 year]

      Record the number of placental abruption in each group and compare whether there are statistical differences in the incidence of each group

    4. Postpartum hemorrhage [1 year]

      Record the number of postpartum hemorrhage in each group and compare whether there are statistical differences in the incidence of each group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The Third Affiliated Hospital of Guangzhou Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Third Affiliated Hospital of Guangzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT04656665
    Other Study ID Numbers:
    • ThirdGuangzhouMU
    First Posted:
    Dec 7, 2020
    Last Update Posted:
    Mar 10, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The Third Affiliated Hospital of Guangzhou Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 10, 2021