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

• Status: Not yet recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Collaborators: Obstetrics & Gynecology Hospital of Fudan University; Peking University First Hospital; Shanghai First Maternity and Infant Hospital; West China Second University Hospital
• Treatments: Aspirin; Metformin

Criteria

Inclusion Criteria:

• Singleton pregnancies

• Live fetus at 11-13 weeks' gestation

• High-risk for preterm preeclampsia at 11-13 weeks by the algorithm combining maternal characteristics, medical and obstetric history, MAP and serum PlGF

• Informed and written consent

Exclusion Criteria:

• Age <18 years old

• Multiple pregnancies

• Treatment with low-dose aspirin and metformin at the time of screening

• Pregnancies complicated by major fetal abnormality identified during the first trimester

• Women with learning difficulties, or serious mental illness

• Bleeding disorders such as Von Willebrand's disease

• Active peptic ulceration or gastrointestinal bleeding

• Hypersensitivity to aspirin, metformin hydrochloride and other biguanides

• Treatment with long term nonsteroidal anti-inflammatory medication

• Hyperemesis gravidarum

• Renal, liver or heart failure

• A serious medical condition

• Concurrent participation in another drug trial or at any time within the previous 28 days

• Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.