Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women

NCT03528967 | Completed Phase 4 DMC

• 1 other identifier: EG01
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Placental Insufficiency; Enoxaparin

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

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

OTHER

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

Interventions

Enoxaparin 40 mg / 0.4 mL Prefilled Syringe DRUG

Arm 1

Aspirin 100 mg Oral Tablet, Enteric Coated DRUG

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Les Laboratoires des Médicaments Stériles: lead

Study Sites (1)

Maternity Center of Wassila Bourguiba Hospital - Department A

Tunis, Tunisia

Location

MeSH Terms

Conditions

Placental Insufficiency

Interventions

Enoxaparin; Aspirin; Tablets

Condition Hierarchy (Ancestors)

Placenta Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Dalenda Chelly, OB/GYN

  Wassila Bourguiba Hospital Tunis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 18, 2018
• Study Start: October 23, 2013
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: July 2, 2020

Record last verified: 2018-08

Locations

TU (1)