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Study on the effect of low molecular weight heparin individualized anticoagulant regimens on prevention and treatment of thrombotic diseases in perinatal pregnant women based on Pharmacokinetics

Study on the effect of low molecular weight heparin individualized anticoagulant regimens on prevention and treatment of thrombotic diseases in perinatal pregnant women based on Pharmacokinetics

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036744
Enrollment
Unknown
Registered
2020-08-25
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

Thrombotic disorders of pregnancy

Interventions

Control group:Blood samples were drawn to detect anti XA factor and coagulation index, and the drugs were used empirically
experimental group:Blood samples were drawn to detect anti XA factor and coagulation index, and the dosage was adjusted according to the dose adjustment table

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) The degree of venous thromboembolism was 0-III grade. 2) Pregnant women who are healthy before pregnancy, singleton. 3) The age was 18-45 years old and the gestational age was 34-40 weeks. 4) The detection range of atiiii is 70% - 130%. 5) Informed consent signed by patients.

Exclusion criteria

Exclusion criteria: 1) Severe active bleeding (brain, digestive tract, urinary system or other parts); 2) High risk pregnancy; 3) Primary hypertension, diabetes, intrauterine infection, heart disease; 4) Patients with severe liver and kidney insufficiency, blood diseases and autoimmune diseases; 5) Chronic consumptive disease, lower limb paralysis or acute spinal cord injury, abnormal lipid metabolism; 6) Patients who have taken drugs interfering with fibrinolysis and coagulation in recent 2 weeks; 7) Incomplete clinical data; 8) Drop out of the study; 9) Cerebrovascular events (cerebral infarction, cerebral hemorrhage) occurred within 3 months; 10) Severe bleeding and coagulation dysfunction; 11) Liver failure; 12) History of abortion; 13) Combined with peptic ulcer, gastrointestinal malignant tumor, intracranial tumor; 14) Hypertension patients without good control: systolic blood pressure >= 180 mmHg, diastolic blood pressure >= 110 mmHg 15) The patient is allergic to the test drug; 16) The patient has a history of alcoholism / drug abuse; 17) Combined use of other anticoagulant drugs or drugs with influence on anticoagulant drug metabolism.

Design outcomes

Primary

MeasureTime frame
Anti XA factor;Coagulation index;

Secondary

MeasureTime frame
Pregnancy complications;Pregnancy outcome;

Countries

China

Contacts

Public ContactXie Hongjuan

Shanghai First Maternity and Infant Hospital

xiehongjuan@51mch.com+86 18930871311

Outcome results

None listed

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