Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Preeclampsia

Treatments: Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT04631627

EPRPLACC

Details and patient eligibility

About

This study intends to adopt the method of multi-center prospective randomized controlled study. The aim of this study is to obtain localized excision values through a preeclampsia screening model established in early pregnancy, and to evaluate the efficacy of low-dose aspirin intervention for preeclampsia prevention in pregnant women at high risk of screening.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1)Pregnant women assessed as at high risk of preeclampsia 2) live pregnancy 3) gestational weeks < 16 weeks 4) agree to randomized drug intervention studies 5) follow up regularly and obtain reliable pregnancy outcomes

Exclusion criteria

• 1)with severe fetal or chromosomal abnormalities 2) induced labor or spontaneous abortion due to social factors 3) absolute or relative contraindications to aspirin use (allergy to aspirin or other salicylate, or other ingredients of the drug;Acute gastrointestinal ulcer;Active bleeding;In patients with severe G6PD deficiency, acetylsalicylic acid may induce hemolysis or hemolytic anemia.Aspirin asthma)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,500 participants in 2 patient groups

aspirin group

Active Comparator group

Description:

aspirin,tablet,100/150mg per day,(BMI\<30 100mg/d，BMI≥30 150mg/d)，from pregnancy weeks\<16 to 35 weeks or the day of delivery.

Treatment:

Drug: Aspirin

control group

Sham Comparator group

Description:

with no intervention

Treatment:

Drug: Aspirin