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Assessment of the effectiveness of Enoxaparin, at a preventive dose, combined with Aspirin treatment versus Aspirin only treatment in reducing placental insufficiency in pregnant women.
Randomized, prospective, monocentric, open-label comparative study with two parallel groups (Enoxaparin, at a preventive dose, combined with Aspirin versus Aspirin alone), with the main objective being to evaluate the effectiveness of enoxaparin, at a preventive dose, in reducing placental insufficiency during pregnancy in pregnant women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients going on ASPIRIN 100 mg/day combined with ENOXAPARIN 4000 IU per dat prevention treatment according to randomization:
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| Arm 2 | Other | Patients going on ASPIRIN 100 mg/day prevention treatment alone according to randomization:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin 40 mg / 0.4 mL Prefilled Syringe | Drug |
| ||
| Aspirin 100 mg Oral Tablet, Enteric Coated |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of maternal death | To compare the incidence of maternal death between the two arms of the study. | 7 - 42 weeks of amenorrhea |
| Recurrence rate of preeclampsia | To compare the recurrence rate of preeclampsia between the two arms of the study. | 7 - 42 weeks of amenorrhea |
| Incidence of intrauterine growth restriction (IUGR) | To compare the incidence of IUGR between the two arms of the study. | 7 - 42 weeks of amenorrhea |
| Incidence of retroplacental hematoma (RPH) | To compare the incidence of RPH between the two arms of the study. | 7 - 42 weeks of amenorrhea |
| Incidence of perinatal death | To compare the incidence of perinatal death between the two arms of the study. | 7 - 42 weeks of amenorrhea |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of miscarriage | To compare the incidence of miscarriage between the two arms of the study. | 13 - 21 weeks of amenorrhea |
| Incidence of in utero fetal death (IUFD) | To compare the incidence of IUFD between the two arms of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalenda Chelly, OB/GYN | Wassila Bourguiba Hospital Tunis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternity Center of Wassila Bourguiba Hospital - Department A | Tunis | Tunisia |
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| ID | Term |
|---|---|
| D010927 | Placental Insufficiency |
| ID | Term |
|---|---|
| D010922 | Placenta Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| D001241 | Aspirin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Drug |
|
| 22 weeks of amenorrhea at birth |
| Incidence of neonatal death | To compare the incidence of neonatal death between the two arms of the study. | From birth to 28 days of life |
| Number of adverse events | To compare the safety of both study products | 7 - 42 weeks of amenorrhea |
| D002241 |
| Carbohydrates |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |