Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women

Placental Insufficiency Clinical Trial

— PRESANCE  

Official title:

Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528967
• Other study ID #: EG01
• Status: Completed
• Phase: Phase 4
• Start date: October 23, 2013
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2018
• Source: Les Laboratoires des Médicaments Stériles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Enoxaparin
• Placental Insufficiency

Intervention

Drug:
• Enoxaparin 40 mg / 0.4 mL Prefilled Syringe

• Aspirin 100 mg Oral Tablet, Enteric Coated

Locations

Country	Name	City	State
Tunisia	Maternity Center of Wassila Bourguiba Hospital - Department A	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Les Laboratoires des Médicaments Stériles

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of maternal death	To compare the incidence of maternal death between the two arms of the study.	7 - 42 weeks of amenorrhea
Primary	Recurrence rate of preeclampsia	To compare the recurrence rate of preeclampsia between the two arms of the study.	7 - 42 weeks of amenorrhea
Primary	Incidence of intrauterine growth restriction (IUGR)	To compare the incidence of IUGR between the two arms of the study.	7 - 42 weeks of amenorrhea
Primary	Incidence of retroplacental hematoma (RPH)	To compare the incidence of RPH between the two arms of the study.	7 - 42 weeks of amenorrhea
Primary	Incidence of perinatal death	To compare the incidence of perinatal death between the two arms of the study.	7 - 42 weeks of amenorrhea
Secondary	Incidence of miscarriage	To compare the incidence of miscarriage between the two arms of the study.	13 - 21 weeks of amenorrhea
Secondary	Incidence of in utero fetal death (IUFD)	To compare the incidence of IUFD between the two arms of the study.	22 weeks of amenorrhea at birth
Secondary	Incidence of neonatal death	To compare the incidence of neonatal death between the two arms of the study.	From birth to 28 days of life
Secondary	Number of adverse events	To compare the safety of both study products	7 - 42 weeks of amenorrhea