Aspirin Discontinuation at 28 or 36 Weeks' Gestation in High-Risk Pregnant Women of Preeclampsia A Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
FANG HE
RECRUITING
Guangzhou
Contact Information
Primary
Fang He, M.D
hefangjnu@126.com
+86 13724831279
Backup
Qingwen Nie, Master
qw0621n@163.com
+86 15622149953
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 1800
Treatments
Experimental: Aspirin discontinuation group
initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, receiving 1:1 randomized grouping at 24-27+6 weeks of gestation, discontinuing aspirin at 28 weeks of gestation.
Active_comparator: Control group
initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, receiving 1:1 randomized grouping at 24-27+6 weeks of gestation, continuing aspirin until 36 weeks of gestation.
Related Therapeutic Areas
Sponsors
Leads: FANG HE

This content was sourced from clinicaltrials.gov