Placental Insufficiency, Enoxaparin
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGEnoxaparin 40 mg / 0.4 mL Prefilled Syringe
Sponsors
Les Laboratoires des Médicaments Stériles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years and * Age ≤ 45 years and * Single and confirmed pregnancy and * Intrauterine growth restriction (IUGR) history with an estimated fetal weight (ESW) \< 3rd percentile and / or * In utero fetal death (IUFD) history \> 12 weeks of amenorrhea (WA) and / or * Central Retroplacental hematoma (RPH) history \< 34 WA and / or * History of severe preeclampsia \< 34 WA and * Informed consent, written and obtained
Exclusion criteria
* Age \<18 years or * Age \> 45 years or * Multiple pregnancy or * Pregnancy \> 7 WA or * Positive immunological assessment or * Known history of Thromboembolic diseases, Hemorrhagic diseases, Systemic Lupus Erythematosus (SLE), Heparin-induced thrombocythemia (HIT), Suspicion of thrombophilia (burdened history) or an episode of Deep Vein Thrombosis (DVT) or * Anticoagulation required or * Thrombocythaemia \< 100,000 plq / µl or * Weight \> 100 kg or * Osteoporosis or * Known allergy to the study products or * Inability to ensure injections' administration or * Family history of DVT before 40 years of age or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of perinatal death | 7 - 42 weeks of amenorrhea | To compare the incidence of perinatal death between the two arms of the study. |
| Incidence of maternal death | 7 - 42 weeks of amenorrhea | To compare the incidence of maternal death between the two arms of the study. |
| Recurrence rate of preeclampsia | 7 - 42 weeks of amenorrhea | To compare the recurrence rate of preeclampsia between the two arms of the study. |
| Incidence of intrauterine growth restriction (IUGR) | 7 - 42 weeks of amenorrhea | To compare the incidence of IUGR between the two arms of the study. |
| Incidence of retroplacental hematoma (RPH) | 7 - 42 weeks of amenorrhea | To compare the incidence of RPH between the two arms of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of in utero fetal death (IUFD) | 22 weeks of amenorrhea at birth | To compare the incidence of IUFD between the two arms of the study. |
| Incidence of neonatal death | From birth to 28 days of life | To compare the incidence of neonatal death between the two arms of the study. |
| Number of adverse events | 7 - 42 weeks of amenorrhea | To compare the safety of both study products |
| Incidence of miscarriage | 13 - 21 weeks of amenorrhea | To compare the incidence of miscarriage between the two arms of the study. |
Countries
Tunisia
Outcome results
None listed