Aspirin Discontinuation in High-Risk Pregnant Women of Preeclampsia

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111079
• Other study ID #: [2023] Ethics Review NO.118
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: The Third Affiliated Hospital of Guangzhou Medical University
• Contact: Fang He, M.D
• Phone: +86 13724831279
• Email: hefangjnu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: December 31, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Pre-Eclampsia
• Preeclampsia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	FANG HE	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
FANG HE

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of preterm preeclampsia	delivery with preeclampsia before 37 weeks of gestation	Within one week after delivery
Secondary	Incidence of early-onset preeclampsia	delivery with preeclampsia before 34 weeks of gestation	Within one week after delivery
Secondary	Incidence of term preeclampsia	delivery with preeclampsia after 37 weeks of gestation	Within one week after delivery
Secondary	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)	Within one week after delivery
Secondary	Incidence of small for gestational age	birth weight below the 10th percentile	Within one week after delivery