Aspirin 150 mg vs 100 mg for Prevention of Preeclampsia in High-Risk Obese Pregnant Women

Aspirin 150 mg vs 100 mg for Prevention of Preeclampsia in High-Risk Obese Pregnant Women: A Multicenter Randomized Controlled Trial

According to the American College of Obstetricians and Gynecologists (ACOG), pregnancy-induced hypertension is defined as a new onset of systolic and/or diastolic blood pressure ≥140/90 mmHg after 20 weeks of gestation, with at least 4 hours between two blood pressure measurements, and blood pressure can return to normal after childbirth. Preeclampsia is defined as the presence of proteinuria or multi-organ dysfunction on the basis of pregnancy-induced hypertension. Obese women are a high-risk group for preeclampsia, and the preventive use of low-dose aspirin (LDA) is one of the currently recognized effective interventions. Obesity, as an independent risk factor for preeclampsia, can increase the risk of the disease by 2 to 3 times. With the rising global obesity rate, the prevention and control of preeclampsia in obese pregnant women has become an important challenge in the field of perinatal medicine. The WHO report indicates that the incidence of preeclampsia in obese women is significantly higher, with a 20-30% increase in preeclampsia risk for every 5-unit increase in BMI. The incidence of preeclampsia in obese women can reach 15-25%. At present, the clinical application of oral aspirin for the prevention of preeclampsia in China mainly follows authoritative consensuses such as the "Guidelines for the Diagnosis and Treatment of Hypertensive Disorders in Pregnancy (2020)", which recommends that high-risk pregnant women (such as those with obesity, chronic hypertension, and a history of preeclampsia in the previous pregnancy) take low-dose aspirin (50-150 mg/d) orally from 12 to 16 weeks of gestation for prevention. However, in actual clinical practice, a dose of 100 mg/d is commonly used, and there is still a lack of clear guidance on whether the dose needs to be adjusted for obese pregnant women. At present, the dose of aspirin mainly used in China is still 100 mg, while foreign studies are more inclined to use 150 mg. Therefore, this study is designed to conduct a randomized controlled trial to compare the efficacy and safety of 100 mg and 150 mg aspirin in preventing preeclampsia in obese pregnant women, to optimize the LDA strategy for the prevention of preeclampsia and provide high-quality evidence for clinical practice.

Study Overview

• Status: Not yet recruiting
• Conditions: Preeclampsia
• Intervention / Treatment: Drug: Aspirin 100mg; Drug: Aspirin 150mg

Detailed Description

This study aims to compare the efficacy and safety of 100 mg and 150 mg aspirin in preventing preeclampsia in obese pregnant women and to optimize the LDA strategy for the prevention of preeclampsia. Obese pregnant women at high risk of preeclampsia will be randomly assigned in a 1:1 ratio at 12-16 weeks of gestation. The control group will take 100 mg of aspirin orally every night, while the experimental group will take 150 mg of aspirin orally every night, until 36+0 to 36+6 weeks of gestation. The incidence of preeclampsia will be compared between the two groups.

• Study Type: Interventional
• Enrollment (Estimated): 1300
• 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: Xinghui Wen, Master; Phone Number: +86 18586810223; Email: xinghuiwen998@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510150
      • Fang He

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age 18-45 years;
2. Pregnancy 12-16 weeks, NT normal;
3. Singleton pregnancy;
4. a.BMI ≥35kg/m²; b. 28≤BMI <35 kg/m², and at least one risk factor: history of preeclampsia, chronic hypertension, type 1 or type 2 diabetes, autoimmune disease (excluding antiphospholipid syndrome), nulliparous, family history of preeclampsia, placental abruption, stillbirth, SGA, more than 10 years between pregnancies, in vitro fertilization-embryo transfer;
5. Sign informed consent

Exclusion Criteria:

• 1. Aspirin allergy or contraindication (such as active gastric ulcer, coagulation disorder); 2. Multiple pregnancies; 3. Other severe comorbidities that may lead to pregnancy complications; 4. Seizures; 5. Renal disease, baseline proteinuria (proteinuria> 3+, or protein-to-creatinine ratio ≥ 0.3); 6. Patients taking aspirin for other reasons (such as stroke, heart disease)

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
Active Comparator: Aspirin 100mg; Aspirin 100mg qn was started from 12-16 weeks of gestation and discontinued from 36+0-36+6 weeks of gestation	Drug: Aspirin 100mg; Aspirin 100mg qn was started from 12-16 weeks of gestation and discontinued from 36+0-36+6 weeks of gestation
Experimental: Aspirin 150mg; Aspirin 150mg qn was started from 12-16 weeks of gestation and discontinued from 36+0-36+6 weeks of gestation	Drug: Aspirin 150mg; Aspirin 150mg qn was started from 12-16 weeks of gestation and discontinued from 36+0-36+6 weeks of gestation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of preeclampsia	Hypertension and proteinuria or other organ dysfunction occur after 20 weeks of gestation	Within one week of delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe preeclampsia and hypertensive disorders of pregnancy	Severe preeclampsia or hypertensive disorders of pregnancy occur in pregnant women	Within one week of delivery
Outcome of the fetus	The incidence of SGA, premature birth and fetal death in utero	Within one week of delivery
Complications of the mother	The incidence of placental abruption, oligohydramnios, HELLP syndrome, and preeclampsia and postpartum hemorrhage	Within one week of 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 (Estimated): May 7, 2025
• Primary Completion (Estimated): May 6, 2028
• Study Completion (Estimated): May 6, 2028

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; pregnant women; Low-dose aspirin; obese; preeclampsia
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Aspirin
• Other Study ID Numbers: [2025] Ethics Review NO.059

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