About this trial
Low-dose aspirin (LDA) is considered to be the most effective agent to prevent preeclampsia (PE). At present, there is little exploration about the timing of aspirin discontinuation. Most international guidelines default until 36 weeks of gestation or delivery. China Guideline (2020) recommended that aspirin should be preventively used until 26-28 weeks of gestation, but there was little direct evidence. According to the two-stage theory, placental dysplasia before 28 weeks of gestation is the key to developing PE, the significance of aspirin use after 28 weeks of gestation is debatable. If aspirin discontinuation at 28 weeks of gestation is proven to be feasible for preventing preterm PE, it will not only reduce the risk of Perinatal Haemorrhage but also save medical expenses.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At <16 weeks of gestation, normal NT scan
At least 1 high risk factor or at least 2 moderate risk factors
Intend to receive prenatal examination and deliver in this institution
Signed a written informed consent for participation in the study
Disqualifiers
Aspirin initiated after 16 week
Intolerant or allergic to aspirin
Aspirin adherence was <80%
Miscarriage or termination of pregnancy before randomization
Trial design
Parallel
Treatments tested in this trial
aspirin discontinuation
DrugInitiation of aspirin 100mg qn from 12 to 16 weeks of gestation, discontinuing aspirin at 28 weeks of gestation according to randomization at 24-27+6 weeks of gestation.
aspirin continuation
DrugInitiation of aspirin 100mg qn from 12 to 16 weeks of gestation, continuing aspirin until 36 weeks of gestation according to randomization at 24-27+6 weeks of gestation.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of preterm preeclampsia
delivery with preeclampsia before 37 weeks of gestation
Secondary outcomes
Incidence of early-onset preeclampsia
delivery with preeclampsia before 34 weeks of gestation
Incidence of term preeclampsia
delivery with preeclampsia after 37 weeks of gestation
Incidence of gestational hypertension
new onset of high blood pressure after 20 weeks of gestation (systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg)
Incidence of small for gestational age
birth weight below the 10th percentile
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
FANG HE
Lead sponsor
The Third Affiliated Hospital of Guangzhou Medical University
Sponsor institution