## Protocol Section
### Identification Module
**NCT ID:** NCT06111079

**Brief Title:** Aspirin Discontinuation in High-Risk Pregnant Women of Preeclampsia

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

#### Organization Study ID Info
**ID:** [2023] Ethics Review NO.118
#### Organization
**Class:** OTHER
**Full Name:** The Third Affiliated Hospital of Guangzhou Medical University
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-19

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-18

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-01

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Study First Submit Date:** 2023-10-23
**Study First Submit QC Date:** 2023-10-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** FANG HE

#### Responsible Party

**Investigator Affiliation:** The Third Affiliated Hospital of Guangzhou Medical University

**Investigator Full Name:** FANG HE

**Investigator Title:** Chief Physician/Professor of the Obstetrics Department

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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%.

### Conditions Module

**Conditions:**

- Preeclampsia

- Perinatal Haemorrhage

**Keywords:**

- low dose aspirin

- prevention

- preeclampsia

- pregnancy outcomes

- randomized controlled trial

- aspirin discontinuation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1800

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: aspirin discontinuation

**Label:** Aspirin discontinuation group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: aspirin continuation

**Label:** Control group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Aspirin discontinuation group

**Description:** 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.

**Name:** aspirin discontinuation

**Other Names:**

- initiation of aspirin in early pregnancy

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** 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.

**Name:** aspirin continuation

**Other Names:**

- initiation of aspirin in early pregnancy

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** delivery with preeclampsia before 37 weeks of gestation

**Measure:** Incidence of preterm preeclampsia

**Time Frame:** Within one week after delivery

#### Secondary Outcomes

**Description:** delivery with preeclampsia before 34 weeks of gestation

**Measure:** Incidence of early-onset preeclampsia

**Time Frame:** Within one week after delivery

**Description:** delivery with preeclampsia after 37 weeks of gestation

**Measure:** Incidence of term preeclampsia

**Time Frame:** Within one week after delivery

**Description:** 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)

**Measure:** Incidence of gestational hypertension

**Time Frame:** Within one week after delivery

**Description:** birth weight below the 10th percentile

**Measure:** Incidence of small for gestational age

**Time Frame:** Within one week after delivery

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hefangjnu@126.com

**Name:** Fang He, M.D

**Phone:** +86 13724831279

**Role:** CONTACT

**Contact 2:**

**Email:** qw0621n@163.com

**Name:** Qingwen Nie, Master

**Phone:** +86 15622149953

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Email:** hefangjnu@126.com

- **Name:** FANG HE, M.D

- **Phone:** 13724831279

- **Role:** CONTACT

***Contact 2:***

- **Email:** qw0621n@163.com

- **Name:** Qingwen Nie, Master

- **Phone:** 15622149953

- **Role:** CONTACT

**Country:** China

**Facility:** FANG HE

**State:** Guangdong

**Status:** RECRUITING

**Zip:** 510150

#### Overall Officials

**Official 1:**

**Affiliation:** The Third Affiliated Hospital of Guangzhou Medical University

**Name:** Fang He, M.D

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000046110

- Term: Hypertension, Pregnancy-Induced

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Hemorrhage

- ID: M14106

- Name: Pre-Eclampsia

- Relevance: HIGH

- As Found: Preeclampsia

- ID: M7633

- Name: Eclampsia

- Relevance: LOW

- As Found: Unknown

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M25635

- Name: Hypertension, Pregnancy-Induced

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T2019

- Name: Eclampsia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011225

- Term: Pre-Eclampsia

- ID: D000006470

- Term: Hemorrhage

### Intervention Browse Module - Ancestors

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000005343

- Term: Fibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000010975

- Term: Platelet Aggregation Inhibitors

- ID: D000016861

- Term: Cyclooxygenase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000058633

- Term: Antipyretics

### Intervention Browse Module - Browse Branches

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4548

- Name: Aspirin

- Relevance: HIGH

- As Found: Progression

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8473

- Name: Fibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M13865

- Name: Platelet Aggregation Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19209

- Name: Cyclooxygenase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M29176

- Name: Antipyretics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001241

- Term: Aspirin

### Misc Info Module

- Version Holder: 2024-05-24
