Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT03528967
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2018-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010927', 'term': 'Placental Insufficiency'}], 'ancestors': [{'id': 'D010922', 'term': 'Placenta Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-30', 'studyFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of maternal death', 'timeFrame': '7 - 42 weeks of amenorrhea', 'description': 'To compare the incidence of maternal death between the two arms of the study.'}, {'measure': 'Recurrence rate of preeclampsia', 'timeFrame': '7 - 42 weeks of amenorrhea', 'description': 'To compare the recurrence rate of preeclampsia between the two arms of the study.'}, {'measure': 'Incidence of intrauterine growth restriction (IUGR)', 'timeFrame': '7 - 42 weeks of amenorrhea', 'description': 'To compare the incidence of IUGR between the two arms of the study.'}, {'measure': 'Incidence of retroplacental hematoma (RPH)', 'timeFrame': '7 - 42 weeks of amenorrhea', 'description': 'To compare the incidence of RPH between the two arms of the study.'}, {'measure': 'Incidence of perinatal death', 'timeFrame': '7 - 42 weeks of amenorrhea', 'description': 'To compare the incidence of perinatal death between the two arms of the study.'}], 'secondaryOutcomes': [{'measure': 'Incidence of miscarriage', 'timeFrame': '13 - 21 weeks of amenorrhea', 'description': 'To compare the incidence of miscarriage between the two arms of the study.'}, {'measure': 'Incidence of in utero fetal death (IUFD)', 'timeFrame': '22 weeks of amenorrhea at birth', 'description': 'To compare the incidence of IUFD between the two arms of the study.'}, {'measure': 'Incidence of neonatal death', 'timeFrame': 'From birth to 28 days of life', 'description': 'To compare the incidence of neonatal death between the two arms of the study.'}, {'measure': 'Number of adverse events', 'timeFrame': '7 - 42 weeks of amenorrhea', 'description': 'To compare the safety of both study products'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Placental Insufficiency', 'Enoxaparin']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years and\n* Age ≤ 45 years and\n* Single and confirmed pregnancy and\n* Intrauterine growth restriction (IUGR) history with an estimated fetal weight (ESW) \\< 3rd percentile and / or\n* In utero fetal death (IUFD) history \\> 12 weeks of amenorrhea (WA) and / or\n* Central Retroplacental hematoma (RPH) history \\< 34 WA and / or\n* History of severe preeclampsia \\< 34 WA and\n* Informed consent, written and obtained\n\nExclusion Criteria:\n\n* Age \\<18 years or\n* Age \\> 45 years or\n* Multiple pregnancy or\n* Pregnancy \\> 7 WA or\n* Positive immunological assessment or\n* 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\n* Anticoagulation required or\n* Thrombocythaemia \\< 100,000 plq / µl or\n* Weight \\> 100 kg or\n* Osteoporosis or\n* Known allergy to the study products or\n* Inability to ensure injections' administration or\n* Family history of DVT before 40 years of age or"}, 'identificationModule': {'nctId': 'NCT03528967', 'acronym': 'PRESANCE', 'briefTitle': 'Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Les Laboratoires des Médicaments Stériles'}, 'officialTitle': 'Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes', 'orgStudyIdInfo': {'id': 'EG01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Patients going on ASPIRIN 100 mg/day combined with ENOXAPARIN 4000 IU per dat prevention treatment according to randomization:\n\n* Administer Aspirin 100 mg Oral Tablet, Enteric Coated once daily\n* Administer the Enoxaparin preventive dose of 4000 IU as a subcutaneous Enoxaparin 40 mg / 0.4 mL Prefilled Syringe once daily\n* Start treatment from inclusion visit\n* 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)', 'interventionNames': ['Drug: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe', 'Drug: Aspirin 100 mg Oral Tablet, Enteric Coated']}, {'type': 'OTHER', 'label': 'Arm 2', 'description': 'Patients going on ASPIRIN 100 mg/day prevention treatment alone according to randomization:\n\n* Administer only Aspirin 100 mg Oral Tablet, Enteric Coated once daily\n* Administer orally\n* Start treatment from inclusion visit\n* Maintain treatment until 35 Weeks of Amenorrhea (WA)', 'interventionNames': ['Drug: Aspirin 100 mg Oral Tablet, Enteric Coated']}], 'interventions': [{'name': 'Enoxaparin 40 mg / 0.4 mL Prefilled Syringe', 'type': 'DRUG', 'armGroupLabels': ['Arm 1']}, {'name': 'Aspirin 100 mg Oral Tablet, Enteric Coated', 'type': 'DRUG', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Maternity Center of Wassila Bourguiba Hospital - Department A', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Dalenda Chelly, OB/GYN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wassila Bourguiba Hospital Tunis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Les Laboratoires des Médicaments Stériles', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}