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

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ClinicalTrials.gov Identifier: NCT03528967
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Placental Insufficiency Enoxaparin Drug: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe Drug: Aspirin 100 mg Oral Tablet, Enteric Coated Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes
Actual Study Start Date : October 23, 2013
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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
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



Primary Outcome Measures :
  1. Incidence of maternal death [ Time Frame: 7 - 42 weeks of amenorrhea ]
    To compare the incidence of maternal death between the two arms of the study.

  2. Recurrence rate of preeclampsia [ Time Frame: 7 - 42 weeks of amenorrhea ]
    To compare the recurrence rate of preeclampsia between the two arms of the study.

  3. Incidence of intrauterine growth restriction (IUGR) [ Time Frame: 7 - 42 weeks of amenorrhea ]
    To compare the incidence of IUGR between the two arms of the study.

  4. Incidence of retroplacental hematoma (RPH) [ Time Frame: 7 - 42 weeks of amenorrhea ]
    To compare the incidence of RPH between the two arms of the study.

  5. Incidence of perinatal death [ Time Frame: 7 - 42 weeks of amenorrhea ]
    To compare the incidence of perinatal death between the two arms of the study.


Secondary Outcome Measures :
  1. Incidence of miscarriage [ Time Frame: 13 - 21 weeks of amenorrhea ]
    To compare the incidence of miscarriage between the two arms of the study.

  2. Incidence of in utero fetal death (IUFD) [ Time Frame: 22 weeks of amenorrhea at birth ]
    To compare the incidence of IUFD between the two arms of the study.

  3. Incidence of neonatal death [ Time Frame: From birth to 28 days of life ]
    To compare the incidence of neonatal death between the two arms of the study.

  4. Number of adverse events [ Time Frame: 7 - 42 weeks of amenorrhea ]
    To compare the safety of both study products



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Age ≤ 45 years
  • Single and confirmed pregnancy
  • Intrauterine growth restriction (IUGR) history with an estimated fetal weight (ESW) < 3rd percentile
  • In utero fetal death (IUFD) history > 12 weeks of amenorrhea (WA)
  • Central Retroplacental hematoma (RPH) history < 34 WA
  • History of severe preeclampsia < 34 WA
  • Informed consent, written and obtained

Exclusion Criteria:

  • Age <18 years
  • Age > 45 years
  • Multiple pregnancy
  • Pregnancy > 7 WA
  • Positive immunological assessment
  • 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)
  • Anticoagulation required
  • Thrombocythaemia < 100,000 plq / µl
  • Weight > 100 kg
  • Osteoporosis
  • Known allergy to the study products
  • Inability to ensure injections' administration
  • Family history of DVT before 40 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528967


Locations
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Tunisia
Maternity Center of Wassila Bourguiba Hospital - Department A
Tunis, Tunisia
Sponsors and Collaborators
Les Laboratoires des Médicaments Stériles
Investigators
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Principal Investigator: Dalenda Chelly, OB/GYN Wassila Bourguiba Hospital Tunis

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Responsible Party: Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov Identifier: NCT03528967     History of Changes
Other Study ID Numbers: EG01
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Placental Insufficiency
Placenta Diseases
Pregnancy Complications
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics