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

Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes

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.

Study Overview

• Status: Completed
• Conditions: Placental Insufficiency; Enoxaparin
• Intervention / Treatment: Drug: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe; Drug: Aspirin 100 mg Oral Tablet, Enteric Coated

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia
    • Maternity Center of Wassila Bourguiba Hospital - Department A

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe; Drug: Aspirin 100 mg Oral Tablet, Enteric Coated
Other: 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)	Drug: Aspirin 100 mg Oral Tablet, Enteric Coated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of maternal death	To compare the incidence of maternal death between the two arms of the study.	7 - 42 weeks of amenorrhea
Recurrence rate of preeclampsia	To compare the recurrence rate of preeclampsia between the two arms of the study.	7 - 42 weeks of amenorrhea
Incidence of intrauterine growth restriction (IUGR)	To compare the incidence of IUGR between the two arms of the study.	7 - 42 weeks of amenorrhea
Incidence of retroplacental hematoma (RPH)	To compare the incidence of RPH between the two arms of the study.	7 - 42 weeks of amenorrhea
Incidence of perinatal death	To compare the incidence of perinatal death between the two arms of the study.	7 - 42 weeks of amenorrhea

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of miscarriage	To compare the incidence of miscarriage between the two arms of the study.	13 - 21 weeks of amenorrhea
Incidence of in utero fetal death (IUFD)	To compare the incidence of IUFD between the two arms of the study.	22 weeks of amenorrhea at birth
Incidence of neonatal death	To compare the incidence of neonatal death between the two arms of the study.	From birth to 28 days of life
Number of adverse events	To compare the safety of both study products	7 - 42 weeks of amenorrhea

Collaborators and Investigators

• Sponsor: Les Laboratoires des Médicaments Stériles
• Investigators: Principal Investigator: Dalenda Chelly, OB/GYN, Wassila Bourguiba Hospital Tunis

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2013
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Placenta Diseases; Placental Insufficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Anticoagulants; Aspirin; Enoxaparin
• Other Study ID Numbers: EG01