Aspirin Discontinuation in High-Risk Pregnant Women of Preeclampsia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia; Perinatal Haemorrhage
• Intervention / Treatment: Drug: aspirin discontinuation; Drug: aspirin continuation

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 Type: Interventional
• Enrollment (Estimated): 1800
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Fang He, M.D; Phone Number: +86 13724831279; Email: hefangjnu@126.com
• Study Contact Backup: Name: Qingwen Nie, Master; Phone Number: +86 15622149953; Email: qw0621n@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510150
      • Recruiting
      • FANG HE
      • Contact: FANG HE, M.D; Phone Number: 13724831279; Email: hefangjnu@126.com
      • Contact: Qingwen Nie, Master; Phone Number: 15622149953; Email: qw0621n@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of preterm preeclampsia	delivery with preeclampsia before 37 weeks of gestation	Within one week after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of early-onset preeclampsia	delivery with preeclampsia before 34 weeks of gestation	Within one week after delivery
Incidence of term preeclampsia	delivery with preeclampsia after 37 weeks of gestation	Within one week after delivery
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
Incidence of small for gestational age	birth weight below the 10th percentile	Within one week after delivery

Collaborators and Investigators

• Sponsor: FANG HE
• Investigators: Principal Investigator: Fang He, M.D, The Third Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; prevention; pregnancy outcomes; preeclampsia; low dose aspirin; aspirin discontinuation
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemorrhage; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: [2023] Ethics Review NO.118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No