Status:
NOT_YET_RECRUITING
Effect of Low Molecular Heparin on Pregnancy Outcome With Protein S Deficiency
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Beijing Obstetrics and Gynecology Hospital
Beijing Hospital
Conditions:
Pregnancy Related
Protein S Deficiency
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief Summary
To evaluate whether low molecular heparin could improve pregnancy outcomes in pregnancies with protein S deficiency.
Detailed Description
This is a parallel-group, multicenter, randomized controlled trial of 48 pregnancies with protein S deficiency in China. Patients are randomized into three groups to receive enoxaparin combined with a...
Eligibility Criteria
Inclusion
- Plasma activity levels of PS when not pregnant are below the lower limits of the adult reference values (generally about 60-70% for PS) without the use of warfarin. Or, free protein S antigen levels in the second and third trimesters are less than 30% and less than 24%, respectively
- Pregnant women who delivered from Aug 1st, 2024 to Oct 15th, 2027
- One or more family members exhibiting the same symptoms as the patient
- Past history of early onset thrombosis (age 50 or below)
- Repeated recurrence of thrombosis
- Thromboses in unusual sites
- New onset of thrombosis during current pregnancy or after delivery
- Patients with diagnosis confirmed by gene analysis Inclusion criteria 1 and 2 must always be met regardless of items of 3-8.
- Written informed consent
Exclusion
- Thrombophilia other than Protein S deficiency
- Antiphospholipid syndrome, systemic lupus erythematosus, platelet abnormalities, vascular disorders, blood flow obstruction, paroxysmal nocturnal hemoglobinuria, malignant tumor and other conditions that tend to cause thrombosis
- Allergy/hypersensitivity to enoxaparin or aspirin
- Heparin-associated thrombocytopenia or thrombocytopenia (platelet count\<75 × 10\^9/L)
- Organ lesions at risk for bleeding such as acute stomach/bowel ulcers, cerebral hemorrhage, cerebral aneurysm
- uncontrolled hypertension or Severe hypertension (Systolic Blood Pressure \>200mmhg and/or Diastolic Blood Pressure \>120mmHg)
- Severe hepatic failure (INR \>1.8)
- Serum creatinine greater than 80 umol/L (1.3mg/dl) and an abnormal 24 hour urine creatine clearance (\<30ml/min)
- Abnormal uterine cavity on hysterosalpingogram/hysteroscopy
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06531525
Start Date
August 1 2024
End Date
December 31 2027
Last Update
August 1 2024
Active Locations (1)
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1
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing/Beijing, China, 100010