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

NCT06952712 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: [2025] Ethics Review NO.059
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia

Keywords

Low-dose aspirin; preeclampsia; obese; pregnant women; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• The incidence of preeclampsia

  Hypertension and proteinuria or other organ dysfunction occur after 20 weeks of gestation

  Within one week of delivery

Secondary Outcomes (3)

• Incidence of severe preeclampsia and hypertensive disorders of pregnancy

  Within one week of delivery

• Outcome of the fetus

  Within one week of delivery

• Complications of the mother

  Within one week of delivery

Study Arms (2)

Aspirin 100mg

ACTIVE COMPARATOR

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 150mg

EXPERIMENTAL

Aspirin 150mg qn was started from 12-16 weeks of gestation and discontinued from 36+0-36+6 weeks of gestation

Drug: Aspirin 150mg

Interventions

Aspirin 100mg DRUG

Aspirin 100mg qn was started from 12-16 weeks of gestation and discontinued from 36+0-36+6 weeks of gestation

Aspirin 100mg

Aspirin 150mg DRUG

Aspirin 150mg qn was started from 12-16 weeks of gestation and discontinued from 36+0-36+6 weeks of gestation

Aspirin 150mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 years;
• Pregnancy 12-16 weeks, NT normal;
• Singleton pregnancy;
• 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;
• Sign informed consent

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• FANG HE: lead

Study Sites (1)

Fang He

Guangzhou, Guangdong, 510150, China

Location

MeSH Terms

Conditions

Pre-Eclampsia; Obesity

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Fang He, M.D

  The Third Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang He, M.D

CONTACT

+86 13724831279; hefangjnu@126.com

Xinghui Wen, Master

CONTACT

+86 18586810223; xinghuiwen998@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician/Professor of the Obstetrics Department

Model Details: Obese pregnant women with normal NT scan results and risk factors for preeclampsia were included. They were randomly assigned in a 1:1 ratio at 12-16 weeks of gestation. The control group took 100 mg of aspirin orally every night, while the experimental group took 150 mg of aspirin orally every night, until 36+0 to 36+6 weeks of gestation.

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 1, 2025
• Study Start: May 7, 2025
• Primary Completion (Estimated): May 6, 2028
• Study Completion (Estimated): May 6, 2028
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)