Aspirin Discontinuation in High-Risk Pregnant Women of Preeclampsia

Phase 3

Recruiting

• Conditions: Perinatal Haemorrhage; Preeclampsia
• Interventions: Drug: aspirin discontinuation; Drug: aspirin continuation

• Registration Number: NCT06111079
• Lead Sponsor: FANG HE

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.

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 Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-26
• Study Start: 2023-11-01
• Study First Posted: 2023-11-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1800

Inclusion Criteria

1. At <16 weeks of gestation, normal NT scan
2. At least 1 high risk factor or at least 2 moderate risk factors
3. Intend to receive prenatal examination and deliver in this institution
4. Signed a written informed consent for participation in the study

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin discontinuation group	aspirin discontinuation	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.
Control group	aspirin continuation	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.

Primary Outcome Measures

Name	Time	Method
Incidence of preterm preeclampsia	Within one week after delivery	delivery with preeclampsia before 37 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Incidence of small for gestational age	Within one week after delivery	birth weight below the 10th percentile
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)

Trial Locations

Locations (1)

FANG HE; 🇨🇳 Guangzhou, Guangdong, China