Effect of Low Molecular Heparin on Pregnancy Outcome With Protein S Deficiency

Официальное название

A Multicenter, Open-label, Randomized, Controlled, Phase 2 Trial Evaluating Whether Low Molecular Heparin Could Improve Pregnancy Outcomes With Protein S Deficiency

Обзор

To evaluate whether low molecular heparin could improve pregnancy outcomes in pregnancies with protein S deficiency.

Подробное описание

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 aspirin, aspirin alone and no intervention. The primary outcome measure is livebirth rate.

Вмешательства

• Препарат Enoxaparin
  Enoxaparin 4000 IU/day by subcutaneous injection at the time of randomization and continued until delivery. Dose adjustments were made throughout the study based on symptoms such as bleeding and thrombosis.
• Препарат Aspirin
  Aspirin 75mg, orally, once daily at the time of randomization and continued until delivery. Dose adjustments were made throughout the study based on symptoms such as bleeding and thrombosis.
• Препарат Enoxaparin
  Participants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum.

Первичные конечные точки

• Rate of livebirth [Срок оценки: From date of randomization until delivery, assessed up to 42 months]

Вторичные конечные точки (6)

• Parameters of maternal coagulation-related indicators [Срок оценки: From the start of study treatment to 6 weeks post-partum]
• Parameters to assess the safety of low molecular heparin [Срок оценки: From the start of study treatment to 6 weeks post-partum]
• Other incidents of adverse pregnancy outcomes [Срок оценки: up to 37 weeks]
• Neonatal Data [Срок оценки: after the delivery (an expected average of one month)]
• Incidents of placental insufficiency [Срок оценки: up to 6 weeks post-partum]
• Incidents of thrombosis/thromboembolism [Срок оценки: From the start of study treatment to 6 weeks post-partum]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Peking University Insititute of Hematology, Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT06531525 · PKU-PS-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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