NCT05580523

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All women with singleton pregnancies who are attending for their routine hospital visit at 11-13 weeks' gestation will be invited to undergo screening for preeclampsia. We use a Bayes theorem-based method that combines maternal characteristics, medical and obstetric history together with mean arterial pressure (MAP) and serum placental growth factor (PlGF) level. Women who are deemed high-risk following first trimester combined screening (cutoff corresponding to a screen positive rate of 10%, e.g ≥1 in 80) will be invited to participate in the 3-arm randomized controlled trial.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-03
• Primary completion: 2025-01-01
• Completion: 2025-11-30
• First posted: 2022-10-14
• Last updated: 2023-11-08

Locations

6 sites across 1 country: China