Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women

Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes

Sponsors

Lead Sponsor: Les Laboratoires des Médicaments Stériles

Source Les Laboratoires des Médicaments Stériles
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.

Overall Status Completed
Start Date October 23, 2013
Completion Date July 31, 2018
Primary Completion Date July 31, 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of maternal death 7 - 42 weeks of amenorrhea
Recurrence rate of preeclampsia 7 - 42 weeks of amenorrhea
Incidence of intrauterine growth restriction (IUGR) 7 - 42 weeks of amenorrhea
Incidence of retroplacental hematoma (RPH) 7 - 42 weeks of amenorrhea
Incidence of perinatal death 7 - 42 weeks of amenorrhea
Secondary Outcome
Measure Time Frame
Incidence of miscarriage 13 - 21 weeks of amenorrhea
Incidence of in utero fetal death (IUFD) 22 weeks of amenorrhea at birth
Incidence of neonatal death From birth to 28 days of life
Number of adverse events 7 - 42 weeks of amenorrhea
Enrollment 89
Condition
Intervention

Intervention Type: Drug

Intervention Name: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe

Arm Group Label: Arm 1

Intervention Type: Drug

Intervention Name: Aspirin 100 mg Oral Tablet, Enteric Coated

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Dalenda Chelly, OB/GYN Principal Investigator Wassila Bourguiba Hospital Tunis
Location
Facility: Maternity Center of Wassila Bourguiba Hospital - Department A
Location Countries

Tunisia

Verification Date

August 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm 1

Type: Experimental

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)

Label: Arm 2

Type: Other

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)

Acronym PRESANCE
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov