Aspirin Discontinuation in High-Risk Pregnant Women of Preeclampsia

NCT06111079 | Recruiting Phase 3 DMC

• 1 other identifier: [2023] Ethics Review NO.118
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preeclampsia; Perinatal Haemorrhage

Keywords

low dose aspirin; prevention; preeclampsia; pregnancy outcomes; randomized controlled trial; aspirin discontinuation

Outcome Measures

Primary Outcomes (1)

• Incidence of preterm preeclampsia

  delivery with preeclampsia before 37 weeks of gestation

  Within one week after delivery

Secondary Outcomes (4)

• Incidence of early-onset preeclampsia

  Within one week after delivery

• Incidence of term preeclampsia

  Within one week after delivery

• Incidence of gestational hypertension

  Within one week after delivery

• Incidence of small for gestational age

  Within one week after delivery

Study Arms (2)

Aspirin discontinuation group

EXPERIMENTAL

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.

Drug: aspirin discontinuation

Control group

ACTIVE COMPARATOR

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.

Drug: aspirin continuation

Interventions

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.

Also known as: initiation of aspirin in early pregnancy

Aspirin discontinuation group

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.

Also known as: initiation of aspirin in early pregnancy

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Aspirin initiated after 16 week
• Intolerant or allergic to aspirin
• Aspirin adherence was \<80%
• Miscarriage or termination of pregnancy before randomization
• drop out (do not return to the hospital for delivery).
• Lost to follow-up

Sponsors & Collaborators

• FANG HE: lead

Study Sites (1)

FANG HE

Guangzhou, Guangdong, 510150, China

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Fang He, M.D

  The Third Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang He, M.D

CONTACT

+86 13724831279; hefangjnu@126.com

Qingwen Nie, Master

CONTACT

+86 15622149953; qw0621n@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician/Professor of the Obstetrics Department

Model Details: Pregnant women with normal NT scan who meet at least one high-risk factor or at least two medium-risk factors are included. Initiating aspirin 100mg qn during 12-16 weeks of gestation. At 24-27+6 weeks of gestation, the patients were 1:1 randomly divided into two groups. The experimental group discontinue aspirin at 28 weeks of gestation, and the control group receive aspirin until 36 weeks of gestation.

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 1, 2023
• Study Start: November 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)