Overview
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.
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.
Eligibility
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.