Aspirin Discontinuation in High-Risk Pregnant Women of Preeclampsia

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorFANG HE

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

Qualifiers

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

Treatments tested in this trial

  • aspirin discontinuation
  • aspirin continuation

Treatment groups

1,800 Participants
are divided into 2 treatment groups

Sponsors and collaborators

FANG HE

Lead sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Sponsor institution