Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women

NCT ID: NCT03528967

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-23
• Study Completion Date: 2018-07-31

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.

Conditions

Placental Insufficiency; Enoxaparin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1

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)

Group Type: EXPERIMENTAL

Enoxaparin 40 mg / 0.4 mL Prefilled Syringe

Intervention Type: DRUG

Aspirin 100 mg Oral Tablet, Enteric Coated

Intervention Type: DRUG

Arm 2

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)

Group Type: OTHER

Aspirin 100 mg Oral Tablet, Enteric Coated

Intervention Type: DRUG

Interventions

Enoxaparin 40 mg / 0.4 mL Prefilled Syringe

Intervention Type: DRUG

Aspirin 100 mg Oral Tablet, Enteric Coated

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Les Laboratoires des Médicaments Stériles

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dalenda Chelly, OB/GYN

Role: PRINCIPAL_INVESTIGATOR

Wassila Bourguiba Hospital Tunis

Locations

Maternity Center of Wassila Bourguiba Hospital - Department A

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

EG01

Identifier Type: -

Identifier Source: org_study_id