Aspirin Versus Metformin in Pregnancies at High Risk of Preterm Preeclampsia: a 3-arm Randomized Controlled Trial
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
West China Second University Hospital, Sichuan University
RECRUITING
Chengdu
Guangzhou Women and Children's Medical Center
WITHDRAWN
Guangzhou
The Third Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
Obstetrics and Gynecology Hospital of Fudan University
RECRUITING
Shanghai
Shanghai First Maternity and Infant Hospital
RECRUITING
Shanghai
Contact Information
Primary
Chiu Yee, Liona Poon, MD
liona.poon@cuhk.edu.hk
(852) 3505 1290
Backup
Chi Chiu Wang, PhD
ccwang@cuhk.edu.hk
(852) 3505 3099
Time Frame
Start Date: 2023-07-03
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 3000
Treatments
Experimental: Aspirin 75 mg and placebo
A capsule of 75 mg aspirin plus an aspirin identical-appearing capsule of placebo to be taken orally once per night from enrolment until 36 weeks' gestation and metformin identical-appearing placebo capsules to be taken orally twice per day from enrolment until delivery.
Experimental: Aspirin 150 mg and placebo
Two capsules of 75 mg aspirin to be taken orally once per night from enrolment until 36 weeks' gestation and metformin identical-appearing placebo capsules to be taken orally twice per day from enrolment until delivery.
Experimental: Aspirin 75 mg and Metformin 1.5 g
A capsule of 75 mg aspirin plus an aspirin identical-appearing capsule of placebo to be taken orally once per night from enrolment until 36 weeks' gestation and metformin capsules (up to 750 mg) to be taken twice per day from enrolment until delivery
Related Therapeutic Areas
Sponsors
Collaborators: Obstetrics & Gynecology Hospital of Fudan University, Peking University First Hospital, Shanghai First Maternity and Infant Hospital, West China Second University Hospital
Leads: Chinese University of Hong Kong