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Prevention project on high risk pregnancy complications

Aspirin for preventing placenta-mediated pregnancy complications: A community-based multicenter randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015301
Enrollment
Unknown
Registered
2018-03-22
Start date
2018-03-26
Completion date
Unknown
Last updated
2018-03-26

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

Conditions

Placenta-mediated pregnancy complications

Interventions

Intervention group:Aspirin intake from the first-trimester (before 12 weeks of gestation)
Control group:Aspirin intake from the second-trimester (after 12 weeks of gestation)

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Pregnant women agree to participate in the trial, sign the informed consent form, plan to deliver at Shanghai hospital without relocation plan and meet at least one of the following criteria: (1) Aged = 35 years; (2) Overweight / obesity (pre-pregnancy/pregnancy BMI = 25 kg / m2); (3) Type I or II diabetes; (4) Chronic hypertension; (5) Family history of preeclampsia (mother or sisters); (6) History of adverse pregnancy (pre-eclampsia / eclampsia / gestational hypertension), premature birth or stillbirth; (7) Proteinuria in early pregnancy, kidney disease (nephritis, nephrotic syndrome, renal insufficiency, etc.) . (8) Autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, antiphospholipid syndrome, etc.); (9) Pregnancy interval more than 8 years.

Exclusion criteria

Exclusion criteria: Pregnant women refuse to participate in the trial, or meet at least one of the following criteria: (1) Non-Shanghai childbirth or relocation plan or unable to be followed-up; (2) Serious blood diseases (thrombocytopenia, aplastic anemia, hemophilia, severe anemia (hemoglobin <60g / L), etc.); (3) Malignant tumors, cancer; (4) AIDS; (5) Aspirin allergy or long-term use of non-steroidal anti-inflammatory drugs; (6) Pregnant women themselves suffer from serious illness or mental disorders (such as schizophrenia, epilepsy); (7) Active hepatitis, Cirrhosis; (8) Organic heart disease (rheumatic heart disease, congenital heart disease, coronary heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, etc.) or heart failure; (9) Severe lung disease (active tuberculosis, pulmonary heart disease, etc.); (10) Peptic ulcer patients; (11) Accompanied by other factors that affect compliance.

Design outcomes

Primary

MeasureTime frame
Incidence of placenta-mediated pregnancy complications;

Countries

China

Contacts

Public ContactJun Zhang

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

junjimzhang@sina.com+86 13916649053

Outcome results

None listed

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