The Effectiveness of Aspirin on Preventing Pre-eclampsia

The Effectiveness of Low-dose Aspirin on Preventing Pre-eclampsia in High-risks Pregnant Women

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.

Study Overview

• Status: Unknown
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Drug: Aspirin

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: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Fang He, Dr.; Phone Number: +86020-81292532; Email: hefangjnu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm birth	Record the number of preterm in each group and compare whether there are statistical differences in the incidence of each group	1 year
Fetal growth restriction	Record the number of FGR in each group and compare whether there are statistical differences in the incidence of each group	1 year
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	1 year
Postpartum hemorrhage	Record the number of postpartum hemorrhage in each group and compare whether there are statistical differences in the incidence of each group	1 year

Collaborators and Investigators

• Sponsor: The Third Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2021
• Primary Completion (Anticipated): December 14, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Pre-eclampsia, Aspirin
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: ThirdGuangzhouMU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No