The Effectiveness of Aspirin on Preventing Pre-eclampsia

NCT04656665 | Unknown Phase 4

• 1 other identifier: ThirdGuangzhouMU
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pre-Eclampsia

Keywords

Pre-eclampsia, Aspirin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Preterm birth

  1 year

• Fetal growth restriction

  1 year

• Placental abruption 4/5000 Placental abruption

  1 year

• Postpartum hemorrhage

  1 year

Study Arms (3)

75mg

EXPERIMENTAL

Take 75mg of aspirin daily in tihis group

Drug: Aspirin

100mg

ACTIVE COMPARATOR

Take 100mg of aspirin daily in this group

Drug: Aspirin

blank

NO INTERVENTION

Not taking aspirin in this group

Interventions

Aspirin DRUG

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

Also known as: Acetylsalicylic acid

100mg; 75mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Third Affiliated Hospital of Guangzhou Medical University: lead

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Fang He, Dr.

CONTACT

+86020-81292532; hefangjnu@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: December 7, 2020
• Study Start: March 15, 2021
• Primary Completion: December 14, 2022
• Study Completion: December 31, 2022
• Last Updated: March 10, 2021

Record last verified: 2021-03