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Aspirin Versus Metformin in Pregnancies at High Risk of Preterm Preeclampsia: a 3-arm Randomized Controlled Trial

NCT05580523 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2023-11-08

No results posted yet for this study

Summary

This is a prospective, multicenter, randomized controlled, double-blind trial of three treatment arms: (1) aspirin 75 mg/day vs. (2) aspirin 150 mg/day vs. (3) aspirin 75 mg/day with metformin 1.5 g/day from the first trimester to compare the incidence of preterm preeclampsia with delivery at \<37 week's gestation between the treatment arms, in order to determine the optimal therapeutic intervention for the prevention of preterm preeclampsia among Chinese women at high-risk of preeclampsia.

Conditions

Interventions

DRUG

75 mg acetylsalicylic acid

75 mg acetylsalicylic acid (C9H8O4, CAS number 50-78-2) daily, Oral

DRUG

1.5g Metformin

up to 1.5 g metformin (C4H11N5, CAS number 657-24-9) daily, Oral Dose increases from 0.5g to 1.0g to 1.5g

DRUG

150 mg acetylsalicylic acid

150 mg acetylsalicylic acid (C9H8O4, CAS number 50-78-2) daily, Oral

DRUG

Placebo of acetylsalicylic acid and Metformin

Pills with shape, color and smell same with acetylsalicylic acid and metformin, daily, oral

Sponsors & Collaborators

  • Obstetrics & Gynecology Hospital of Fudan University

    collaborator OTHER

  • Shanghai First Maternity and Infant Hospital

    collaborator OTHER

  • West China Second University Hospital

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Chiu Yee, Liona Poon, MD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-03
Primary Completion
2025-01-01
Completion
2025-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05580523 on ClinicalTrials.gov