Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women (PRESANCE)

Les Laboratoires des Médicaments Stériles

Status and phase: Completed; Phase 4

Conditions: Enoxaparin; Placental Insufficiency

Treatments: Drug: Aspirin 100 mg Oral Tablet, Enteric Coated; Drug: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe

Study type: Interventional

Funder types: Industry

Identifiers

NCT03528967

EG01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Arm 1

Experimental group

Description:

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)

Treatment:

Drug: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe

Drug: Aspirin 100 mg Oral Tablet, Enteric Coated

Arm 2

Other group

Description:

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)

Treatment:

Drug: Aspirin 100 mg Oral Tablet, Enteric Coated