Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women

Phase 4

Completed

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

• Registration Number: NCT03528967
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-10-23
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-18
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2018-08
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Aspirin 100 mg Oral Tablet, Enteric Coated	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 1	Enoxaparin 40 mg / 0.4 mL Prefilled Syringe	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 2	Aspirin 100 mg Oral Tablet, Enteric Coated	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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	7 - 42 weeks of amenorrhea	To compare the safety of both study products
Incidence of neonatal death	From birth to 28 days of life	To compare the incidence of neonatal death between the two arms of the study.
Incidence of miscarriage	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)	22 weeks of amenorrhea at birth	To compare the incidence of IUFD between the two arms of the study.

Trial Locations

Locations (1)

Maternity Center of Wassila Bourguiba Hospital - Department A; 🇹🇳 Tunis, Tunisia