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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • aspirin discontinuation

    Drug

    Initiation 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

    Drug

    Initiation 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

1,800 Participants
are divided into 2 treatment groups
Group A: Aspirin discontinuation groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of preterm preeclampsia

delivery with preeclampsia before 37 weeks of gestation

Time frame
Within one week after delivery

Secondary outcomes

1

Incidence of early-onset preeclampsia

delivery with preeclampsia before 34 weeks of gestation

Time frame
Within one week after delivery
2

Incidence of term preeclampsia

delivery with preeclampsia after 37 weeks of gestation

Time frame
Within one week after delivery
3

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)

Time frame
Within one week after delivery
4

Incidence of small for gestational age

birth weight below the 10th percentile

Time frame
Within one week after delivery

Other outcomes

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