Comparing aspirin and metformin for preventing preterm preeclampsia in high-risk pregnancies
Aspirin Versus Metformin in Pregnancies at High Risk of Preterm Preeclampsia: a 3-arm Randomized Controlled Trial
This study is testing whether different doses of aspirin alone or with metformin can help prevent preterm preeclampsia in high-risk pregnant women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 6 sites (Beijing, Beijing and 5 other locations) |
| Trial ID | NCT05580523 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multicenter, randomized controlled trial that investigates the effectiveness of different doses of aspirin and the addition of metformin in preventing preterm preeclampsia among women identified as high-risk during their first trimester. Participants will be randomly assigned to one of three treatment arms: 75 mg of aspirin, 150 mg of aspirin, or 75 mg of aspirin combined with 1.5 g of metformin daily. The study aims to determine which intervention is most effective in reducing the incidence of preterm preeclampsia, with a focus on Chinese women. Screening for high-risk candidates will utilize a Bayes theorem-based method that incorporates maternal characteristics and medical history.
Who should consider this trial
Good fit: Ideal candidates for this study are women with singleton pregnancies who are at high risk for preterm preeclampsia as determined by specific screening criteria during their first trimester.
Not a fit: Patients who are under 18 years old, have multiple pregnancies, or have certain medical conditions such as bleeding disorders or serious mental illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective prevention strategy for preterm preeclampsia, potentially improving outcomes for both mothers and infants.
How similar studies have performed: Other studies have shown promising results with aspirin in preventing preeclampsia, but the combination with metformin in this specific context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing and 5 other locations
- Peking University First Hospital — Beijing, Beijing, China (Recruiting)
- Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China (Withdrawn)
- The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Obstetrics and Gynecology Hospital of Fudan University — Shanghai, Shanghai, China (Recruiting)
- Shanghai First Maternity and Infant Hospital — Shanghai, Shanghai, China (Recruiting)
- West China Second University Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Chiu Yee, Liona Poon, MD — Chinese University of Hong Kong
- Study coordinator: Chiu Yee, Liona Poon, MD
- Email: liona.poon@cuhk.edu.hk
- Phone: (852) 3505 1290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.