The Effectiveness of Aspirin on Preventing Pre-eclampsia

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04656665
• Other study ID #: ThirdGuangzhouMU
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: The Third Affiliated Hospital of Guangzhou Medical University
• Contact: Fang He, Dr.
• Phone: +86020-81292532
• Email: hefangjnu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 31, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Drug:
• Aspirin
For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated Hospital of Guangzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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