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

L

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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