Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT05319834
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2022-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All participants and investigators'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-12', 'studyFirstSubmitDate': '2022-03-22', 'studyFirstSubmitQcDate': '2022-03-31', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who will deliver before 34 weeks gestation.', 'timeFrame': '18 month', 'description': 'Number of participants who have preterm delivery before 34 weeks gestation'}], 'secondaryOutcomes': [{'measure': 'The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation', 'timeFrame': '18 months', 'description': 'Number of participants who will deliver after 34w gestation and neonatal outcomes'}, {'measure': 'Neonatal outcomes', 'timeFrame': '18 months', 'description': 'Neonatal birth weight Admission to NICU Neonatal complications'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Birth']}, 'descriptionModule': {'briefSummary': 'This is a double blinded randomized placebo controlled clinical trial to detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.', 'detailedDescription': 'The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1), or vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women of any age\n2. Any parity\n3. Healthy singleton pregnancy\n4. History suggestive of one or more previous PTB\n5. Current pregnancy (16-20) weeks gestation.\n\nExclusion Criteria:\n\n1. Multifetal pregnancy.\n2. History of ante partum PROM.\n3. Cervical Incompetence or current cervical cerclage.\n4. Known fetal anomaly.\n5. Hypertension requiring medications.\n6. History of Thrombo-embolic disorders.\n7. Known allergy to progesterone or asprin.\n8. Known liver disease.\n9. Established preterm labor\n10. Short cervix'}, 'identificationModule': {'nctId': 'NCT05319834', 'acronym': 'prematurity', 'briefTitle': 'Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth', 'orgStudyIdInfo': {'id': '3/2020/OBG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Progesterone with asprin', 'description': 'The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1),', 'interventionNames': ['Drug: Aspirin tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Progesterone and placebo', 'description': 'vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aspirin tablet', 'type': 'DRUG', 'otherNames': ['group 1 intervention'], 'description': 'group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone', 'armGroupLabels': ['Progesterone with asprin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['group 2 intervention'], 'description': 'group 2: oral placebo once daily at the same time with progesterone', 'armGroupLabels': ['Progesterone and placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shibīn al Kawm', 'country': 'Egypt', 'facility': 'Menoufia University', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mohamed Maher', 'investigatorAffiliation': 'Menoufia University'}}}}