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Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)
Women will be randomly divided into two groups; one will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy and the other will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester until termination of pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoxaparin group | Active Comparator | Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy |
|
| Warfarin group | Active Comparator | Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | Women will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fetal loss | Unexplained fetal death of morphologically normal fetus after the first trimester | From 12 weeks to 42 weeks gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm delivery | Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency | From 20 weeks to 34 weeks gestational age |
| Intrauterine growth restriction (IUGR) |
| Measure | Description | Time Frame |
|---|---|---|
| Hemorrhagic complications | Hemorrhagic complications | After 12 weeks gestational age up to birth |
| Thromboembolic complications | Thromboembolic complications |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed I Eid, Dr | Contact | +201225401274 | dr_moh_eid@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed I Eid, Dr | Mansoura University | Principal Investigator |
| Mohamed S Abdelhafez, Dr | Mansoura University | Study Director |
| Abdelmageed F Mashaly, Prof |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Department in Mansoura University Hospital | Recruiting | Al Mansurah | Dakahlia Governorate | 35111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32358837 | Derived | Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2. |
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| ID | Term |
|---|---|
| D000026 | Abortion, Habitual |
| D016736 | Antiphospholipid Syndrome |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Warfarin | Drug | Women will be given Enoxaparin (40 mg/day SC) in the first trimester then Warfarin (3-5 mg/day) after the first trimester until termination of pregnancy |
|
|
Birth weight less than the 10th percentile for gestational age
| At birth |
| Congenital fetal malformations | Congenital fetal malformations | At birth |
| After 12 weeks gestational age up to birth |
| Mansoura University |
| Study Chair |
| Private practice settings | Recruiting | Al Mansurah | Dakahlia Governorate | Egypt |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002241 |
| Carbohydrates |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |