Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women

Les Laboratoires des Médicaments Stériles89 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Placental Insufficiency Enoxaparin

Interventions

Enoxaparin 40 mg / 0.4 mL Prefilled SyringeDRUG

Aspirin 100 mg Oral Tablet, Enteric CoatedDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Maternity Center of Wassila Bourguiba Hospital - Department A

Tunis, Tunisia