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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

Tracking Information
First Submitted Date  ICMJE May 7, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date August 16, 2018
Actual Study Start Date  ICMJE October 23, 2013
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03528967 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • Incidence of miscarriage [ Time Frame: 13 - 21 weeks of amenorrhea ]
    To compare the incidence of miscarriage between the two arms of the study.
  • 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.
  • 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.
  • Number of adverse events [ Time Frame: 7 - 42 weeks of amenorrhea ]
    To compare the safety of both study products
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women
Official Title  ICMJE Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Placental Insufficiency
  • Enoxaparin
Intervention  ICMJE
  • Drug: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe
  • Drug: Aspirin 100 mg Oral Tablet, Enteric Coated
Study Arms  ICMJE
  • 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)
    Interventions:
    • 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)
    Intervention: Drug: Aspirin 100 mg Oral Tablet, Enteric Coated
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2018)
89
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2018)
250
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03528967
Other Study ID Numbers  ICMJE EG01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Les Laboratoires des Médicaments Stériles
Study Sponsor  ICMJE Les Laboratoires des Médicaments Stériles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dalenda Chelly, OB/GYN Wassila Bourguiba Hospital Tunis
PRS Account Les Laboratoires des Médicaments Stériles
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP