Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes

Conditions
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Placental Insufficiency, Enoxaparin

Intervention / Treatment
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* Drug: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe
* Drug: Aspirin 100 mg Oral Tablet, Enteric Coated


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Patients going on ASPIRIN 100 mg/day combined with ENOXAPARIN 4000 IU per dat prevention treatment according to randomization: Administer Aspirin 100 mg Oral Tablet, Enteric Coated once daily Administer the Enoxaparin preventive dose of 4000 IU as a subcutaneous Enoxaparin 40 mg / 0.4 mL Prefilled Syringe once daily Start treatment from inclusion visit Maintain treatment until the day of delivery, or the appearance of a complication (Retroplacental hematoma (RPH), preeclampsia (PE) , In utero fetal death (IUFD), or Intrauterine growth restriction (IUGR) and its complications) | Drug: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe<br> <br> Drug: Aspirin 100 mg Oral Tablet, Enteric Coated<br> <br> |
| Other: Arm 2<br>Patients going on ASPIRIN 100 mg/day prevention treatment alone according to randomization: Administer only Aspirin 100 mg Oral Tablet, Enteric Coated once daily Administer orally Start treatment from inclusion visit Maintain treatment until 35 Weeks of Amenorrhea (WA) | Drug: Aspirin 100 mg Oral Tablet, Enteric Coated<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |