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

Sponsor
FANG HE
Study ID
NCT06952712
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
May 1, 2025
Start date
May 7, 2025
Status verified
Apr 2025
Primary completion
May 6, 2028
Completion
May 6, 2028

Study Design

Enrollment
1,300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

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

Primary Outcome Measure

The incidence of preeclampsia [ Time Frame: Within one week of delivery ]

Central Contacts

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