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The Effectiveness of Aspirin on Preventing Pre-eclampsia

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ClinicalTrials.gov Identifier: NCT04656665
Recruitment Status : Not yet recruiting
First Posted : December 7, 2020
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
The Third Affiliated Hospital of Guangzhou Medical University

Tracking Information
First Submitted Date  ICMJE November 11, 2020
First Posted Date  ICMJE December 7, 2020
Last Update Posted Date March 10, 2021
Estimated Study Start Date  ICMJE March 15, 2021
Estimated Primary Completion Date December 14, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of Aspirin on Preventing Pre-eclampsia
Official Title  ICMJE The Effectiveness of Low-dose Aspirin on Preventing Pre-eclampsia in High-risks Pregnant Women
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pre-Eclampsia
Intervention  ICMJE Drug: Aspirin
For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy
Other Name: Acetylsalicylic acid
Study Arms  ICMJE
  • Experimental: 75mg
    Take 75mg of aspirin daily in tihis group
    Intervention: Drug: Aspirin
  • Active Comparator: 100mg
    Take 100mg of aspirin daily in this group
    Intervention: Drug: Aspirin
  • No Intervention: blank
    Not taking aspirin in this group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2020)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 14, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Fang He, Dr. +86020-81292532 hefangjnu@126.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04656665
Other Study ID Numbers  ICMJE ThirdGuangzhouMU
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Third Affiliated Hospital of Guangzhou Medical University
Study Sponsor  ICMJE The Third Affiliated Hospital of Guangzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Third Affiliated Hospital of Guangzhou Medical University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP