search
Back to results

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

Primary Purpose

Placental Insufficiency, Enoxaparin

Status
Completed
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
Enoxaparin 40 mg / 0.4 mL Prefilled Syringe
Aspirin 100 mg Oral Tablet, Enteric Coated
Sponsored by
Les Laboratoires des Médicaments Stériles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placental Insufficiency

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maternity Center of Wassila Bourguiba Hospital - Department A

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm 1

Arm 2

Arm 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)

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)

Outcomes

Primary Outcome Measures

Incidence of maternal death
To compare the incidence of maternal death between the two arms of the study.
Recurrence rate of preeclampsia
To compare the recurrence rate of preeclampsia between the two arms of the study.
Incidence of intrauterine growth restriction (IUGR)
To compare the incidence of IUGR between the two arms of the study.
Incidence of retroplacental hematoma (RPH)
To compare the incidence of RPH between the two arms of the study.
Incidence of perinatal death
To compare the incidence of perinatal death between the two arms of the study.

Secondary Outcome Measures

Incidence of miscarriage
To compare the incidence of miscarriage between the two arms of the study.
Incidence of in utero fetal death (IUFD)
To compare the incidence of IUFD between the two arms of the study.
Incidence of neonatal death
To compare the incidence of neonatal death between the two arms of the study.
Number of adverse events
To compare the safety of both study products

Full Information

First Posted
May 7, 2018
Last Updated
June 30, 2020
Sponsor
Les Laboratoires des Médicaments Stériles
search

1. Study Identification

Unique Protocol Identification Number
NCT03528967
Brief Title
Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women
Acronym
PRESANCE
Official Title
Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 23, 2013 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Les Laboratoires des Médicaments Stériles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placental Insufficiency, Enoxaparin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm 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)
Arm Title
Arm 2
Arm Type
Other
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Enoxaparin 40 mg / 0.4 mL Prefilled Syringe
Intervention Type
Drug
Intervention Name(s)
Aspirin 100 mg Oral Tablet, Enteric Coated
Primary Outcome Measure Information:
Title
Incidence of maternal death
Description
To compare the incidence of maternal death between the two arms of the study.
Time Frame
7 - 42 weeks of amenorrhea
Title
Recurrence rate of preeclampsia
Description
To compare the recurrence rate of preeclampsia between the two arms of the study.
Time Frame
7 - 42 weeks of amenorrhea
Title
Incidence of intrauterine growth restriction (IUGR)
Description
To compare the incidence of IUGR between the two arms of the study.
Time Frame
7 - 42 weeks of amenorrhea
Title
Incidence of retroplacental hematoma (RPH)
Description
To compare the incidence of RPH between the two arms of the study.
Time Frame
7 - 42 weeks of amenorrhea
Title
Incidence of perinatal death
Description
To compare the incidence of perinatal death between the two arms of the study.
Time Frame
7 - 42 weeks of amenorrhea
Secondary Outcome Measure Information:
Title
Incidence of miscarriage
Description
To compare the incidence of miscarriage between the two arms of the study.
Time Frame
13 - 21 weeks of amenorrhea
Title
Incidence of in utero fetal death (IUFD)
Description
To compare the incidence of IUFD between the two arms of the study.
Time Frame
22 weeks of amenorrhea at birth
Title
Incidence of neonatal death
Description
To compare the incidence of neonatal death between the two arms of the study.
Time Frame
From birth to 28 days of life
Title
Number of adverse events
Description
To compare the safety of both study products
Time Frame
7 - 42 weeks of amenorrhea

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalenda Chelly, OB/GYN
Organizational Affiliation
Wassila Bourguiba Hospital Tunis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternity Center of Wassila Bourguiba Hospital - Department A
City
Tunis
Country
Tunisia

12. IPD Sharing Statement

Learn more about this trial

Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women

We'll reach out to this number within 24 hrs