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| Name | Class |
|---|---|
| Beijing Obstetrics and Gynecology Hospital | OTHER |
| Beijing Hospital | OTHER_GOV |
| Peking Union Medical College Hospital | OTHER |
| China-Japan Friendship Hospital |
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To evaluate whether low molecular heparin could improve pregnancy outcomes in pregnancies with protein S deficiency.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The combination group | Experimental | Subjects randomized to the combination group will receive daily injections of enoxaparin at a dose of 4000 IU and aspirin 75mg per day orally until delivery. |
|
| The Aspirin group | Active Comparator | Aspirin will be given at a dose of 75mg, orally, each day until delivery. |
|
| No intervention | No Intervention | No intervention | |
| All groups | Other | Participants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of livebirth | Incidents of livebirth | From date of randomization until delivery, assessed up to 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parameters of maternal coagulation-related indicators | D-Dimer in ng/ml, Protein S activity in % | From the start of study treatment to 6 weeks post-partum |
| Parameters to assess the safety of low molecular heparin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao-Hui Zhang, Professor | Contact | +8613522338836 | zhangxh100@sina.com | |
| Meng-Tong Zang, MD | Contact | 18744579871 | zangztong@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao-Hui Zhang, Professor | Peking University Insititute of Hematology, Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Insititute of Hematology, Peking University People's Hospital | Beijing | Beijing/Beijing | 100010 | China |
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| ID | Term |
|---|---|
| D018455 | Protein S Deficiency |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001796 | Blood Protein Disorders |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| OTHER |
| Sichuan Academy of Medical Sciences | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Chinese PLA General Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
| Beijing Chuiyangliu Hospital | OTHER_GOV |
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|
| Aspirin | Drug | 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. |
|
|
| Enoxaparin | Drug | Participants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum. |
|
|
Maternal platelet count in 10^9/L, Number of haemorrhagic events, Number of cases of skin reactions at injection site
| From the start of study treatment to 6 weeks post-partum |
| Other incidents of adverse pregnancy outcomes | early miscarriage (until 12 weeks of gestation), late miscarriage (12-28 weeks of gestation), premature livebirths (28-37 weeks of gestation) | up to 37 weeks |
| Neonatal Data | Neonatal weight in grams, Neonatal length in centimetres, Apgar 1-minute, 5-minute, 10-minute scores in scores, Number of neonatal complications | after the delivery (an expected average of one month) |
| Incidents of placental insufficiency | Incidents of pre-eclampsia, intrauterine growth retardation, placental abruption, and intrauterine foetal death, etc. | up to 6 weeks post-partum |
| Incidents of thrombosis/thromboembolism | thrombosis/thromboembolism | From the start of study treatment to 6 weeks post-partum |
| D019851 | Thrombophilia |
| D002241 |
| Carbohydrates |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |