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Evaluation of the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)
Women will be randomly divided into two groups; one will start Enoxaparin therapy once positive pregnancy test is established and the other will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given in a dose of 40 mg/day subcutaneously and the therapy will continue until termination of pregnancy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Enoxaparin initiation | Active Comparator | Women will start Enoxaparin therapy once positive pregnancy test is established |
|
| Later Enoxaparin initiation | Active Comparator | Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously once positive pregnancy test is established and the therapy will continue until termination of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rate | Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women | After 12 weeks gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal loss | Unexplained fetal death of morphologically normal fetus after the first trimester | From 20 weeks to 42 weeks gestational age |
| Preterm delivery | Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency |
| Measure | Description | Time Frame |
|---|---|---|
| Hemorrhagic complications | After 12 weeks gestational age up to birth | |
| Thromboembolic complications | After 12 weeks gestational age up to birth |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed I Eid, Dr | Mansoura University | Principal Investigator |
| Mohamed S Abdelhafez, Dr | Mansoura University | Study Director |
| Waleed El-refaie, Dr | Mansoura University | Study Director |
| Ahmed El-Zayadi, Dr | Mansoura University | Study Director |
| Ahmed Badawy, Prof | Mansoura University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Department in Mansoura University Hospital | Al Mansurah | Dakahlia Governorate | 35111 | Egypt | ||
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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 |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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|
| Enoxaparin | Drug | Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously after sonographic confirmation of fetal cardiac pulsation and the therapy will continue until termination of pregnancy |
|
|
| From 20 weeks to 34 weeks gestational age |
| Intrauterine growth restriction (IUGR) | Birth weight less than the 10th percentile for gestational age | At birth |
| Congenital fetal malformations | At birth |
| Private practice settings |
| Al Mansurah |
| Dakahlia Governorate |
| Egypt |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002241 |
| Carbohydrates |