Clinical trial NCT03528967: Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women
Official title: Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Placental Insufficiency
Enoxaparin
Lead sponsor: Les Laboratoires des Médicaments Stériles
Sponsor class: INDUSTRY
First posted: 2018-05-18
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of maternal death
timeFrame: 7 - 42 weeks of amenorrhea
measure: Recurrence rate of preeclampsia
timeFrame: 7 - 42 weeks of amenorrhea
measure: Incidence of intrauterine growth restriction (IUGR)
timeFrame: 7 - 42 weeks of amenorrhea
measure: Incidence of retroplacental hematoma (RPH)
timeFrame: 7 - 42 weeks of amenorrhea
measure: Incidence of perinatal death
timeFrame: 7 - 42 weeks of amenorrhea
Secondary outcomes:
measure: Incidence of miscarriage
timeFrame: 13 - 21 weeks of amenorrhea
measure: Incidence of in utero fetal death (IUFD)
timeFrame: 22 weeks of amenorrhea at birth
measure: Incidence of neonatal death
timeFrame: From birth to 28 days of life
measure: Number of adverse events
timeFrame: 7 - 42 weeks of amenorrhea
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Maternity Center of Wassila Bourguiba Hospital - Department A
Study officials:
affiliation: Wassila Bourguiba Hospital Tunis
name: Dalenda Chelly, OB/GYN
role: PRINCIPAL_INVESTIGATOR
References: