Aspirin Discontinuation in High-Risk Pregnant Women of Preeclampsia

Sponsor

FANG HE (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06111079

Collaborator

(none)

1,800

Enrollment

Location

Arms

Anticipated Duration (Months)

128.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia Perinatal Haemorrhage	Drug: aspirin discontinuation Drug: aspirin continuation	Phase 3

Detailed Description

This study aimed to optimize the strategy of aspirin to prevent preeclampsia, by exploring whether aspirin discontinuation at 28 weeks of gestation to prevent preterm PE is not inferior to 36 weeks of gestation. We will include pregnant women with normal NT scan who meet at least one high-risk factor or at least two medium-risk factors. During 12-16 weeks of gestation, the mean arterial pressure (MAP) and placental growth factor (PlGF) are measured, then initiating aspirin 100mg qn. At 24-27+6 weeks of gestation, the patients were 1:1 randomly divided into two groups, sFlt-1 and PlGF were detected at the same time. The experimental group discontinue aspirin at 28 weeks of gestation, and the control group receive aspirin until 36 weeks of gestation. The incidence of preterm PE in the two groups was compared by non-inferiority test, and the non-inferiority threshold was 2%.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: aspirin discontinuation 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. Other Names: initiation of aspirin in early pregnancy
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.	Drug: aspirin continuation 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. Other Names: initiation of aspirin in early pregnancy

Arm

Intervention/Treatment

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.

Drug: aspirin discontinuation

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.

Other Names:

initiation of aspirin in early pregnancy

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.

Drug: aspirin continuation

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.

Other Names:

initiation of aspirin in early pregnancy

Outcome Measures

Primary Outcome Measures

Incidence of preterm preeclampsia [Within one week after delivery]
delivery with preeclampsia before 37 weeks of gestation

Secondary Outcome Measures

Incidence of early-onset preeclampsia [Within one week after delivery]
delivery with preeclampsia before 34 weeks of gestation
Incidence of term preeclampsia [Within one week after delivery]
delivery with preeclampsia after 37 weeks of gestation
Incidence of gestational hypertension [Within one week after delivery]
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 [Within one week after delivery]
birth weight below the 10th percentile