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Trial record 64 of 308 for:    ASPIRIN AND low-dose aspirin

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

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
Pre-Eclampsia Drug: Aspirin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 15, 2021
Estimated Primary Completion Date : December 14, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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 Name: 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 Name: Acetylsalicylic acid

No Intervention: blank
Not taking aspirin in this group



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04656665


Contacts
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Contact: Fang He, Dr. +86020-81292532 hefangjnu@126.com

Sponsors and Collaborators
The Third Affiliated Hospital of Guangzhou Medical University
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Responsible Party: The Third Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT04656665    
Other Study ID Numbers: ThirdGuangzhouMU
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021

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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:
Pre-eclampsia, Aspirin
Additional relevant MeSH terms:
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Aspirin
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics