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Aspirin for the prevention of preeclampsia based on platelet aggregation rate - a multi-center, stepped-wedge cluster, randomized controlled trial

Aspirin for the prevention of preeclampsia based on platelet aggregation rate - a multi-center, stepped-wedge cluster, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093812
Enrollment
Unknown
Registered
2024-12-12
Start date
2025-07-01
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Interventions

Aspirin dose adjustment intervention group:The dose of aspirin was adjusted according to the platelet aggregation rate (women with aspirin resistance was adjusted to 150mg per day at bedtime)
Routine treatment group:Aspirin 100mg was taken orally before going to bed daily.

Sponsors

Obstetrics and Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Over 18 years old; 2. Singleton pregnancy; 3. 11 weeks ~ 13 weeks and 6 days ultrasound showed fetal survival, which was calculated as high risk (> 1:100) according to the preeclampsia screening algorithm of the Fetal Medical Foundation.

Exclusion criteria

Exclusion criteria: 1. Severe fetal abnormalities found during ultrasound scan at 11 weeks ~ 13 weeks and 6 days of pregnancy; 2. Unviable fetus (spontaneous abortion or stillbirth) 3. Treatment with aspirin within 28 days before NT ultrasound screening; 4. Bleeding disorders (such as von Willebrand disease, peptic ulcer, hypersensitivity to aspirin); 5. Long-term use of non-steroidal anti-inflammatory drugs; 6. Participated in another drug trial within 28 days prior to screening; 7. Refusal to take aspirin; 8. Poor aspirin adherence (medication rate <85%).

Design outcomes

Primary

MeasureTime frame
Incidence of preterm (<37 weeks) preeclampsia;

Secondary

MeasureTime frame
Incidences of pre-eclampsia, gestational hypertension and non-pre-eclampsia intrauterine growth restriction at <34 weeks and =37 weeks;Incidences of gestational hypertension and non-pre-eclampsia intrauterine growth restriction at <37 weeks ;

Countries

China

Contacts

Public ContactWeirong Gu

Obstetrics and Gynecology Hospital of Fudan University

guwieong1237@fckyy.org.cn+86 21 3318 9900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026