Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-30 @ 9:48 AM
Study NCT ID:
NCT03779451
Status:
UNKNOWN
Last Update Posted:
2019-02-15
First Post:
2018-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010923', 'term': 'Placenta Previa'}], 'ancestors': [{'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'}, {'id': 'D010922', 'term': 'Placenta Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'An open-label randomized controlled study'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2018-12-15', 'studyFirstSubmitQcDate': '2018-12-15', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patient delivered before 37 weeks', 'timeFrame': '2 month', 'description': 'calculation the number of patients delivered before 37 weeks'}], 'secondaryOutcomes': [{'measure': 'number of episodes of antepartum hemorrhage', 'timeFrame': '2 month', 'description': 'calculating the mean number of episodes of antepartum hemorrhage'}, {'measure': 'Hospital admission for significant antepartum hemorrhage', 'timeFrame': '2 month', 'description': 'Number of patients requiring hospital admission for significant antepartum hemorrhage'}, {'measure': 'Neonatal Birth weight', 'timeFrame': 'one hours post operative', 'description': 'measure Neonatal Birth weight in kilograms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean section', 'placenta previa', 'antepartum hemorrhage', 'vaginal progesterone', '17-Alpha-Hydroxyprogesterone Caproate'], 'conditions': ['Placenta Previa']}, 'descriptionModule': {'briefSummary': 'Purpose to evaluate the effects of Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with Placenta Previa', 'detailedDescription': 'The study will be a randomized open-label clinical trial conducted at a tertiary university hospital outpatient clinic and some private settings at Aswan governorate, Egypt, between January 2019 and March 2022. The authors will include women who asymptomatic pregnant women with a diagnosed placenta previa at 26-28 weeks gestation. They will be randomized into three groups: group I (vaginal progesterone suppositories ), group II (received an intramuscular dose of 250 mg 17-alpha-Hydroxyprogesterone caproate(17-OHPC) once a week) and group III(control group). In each group, Follow-up visits were performed every week then admission was done at 36 weeks at our university hospital. Scheduled caesarian section was done at completed 37 weeks unless otherwise required.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant women with placenta previa', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age 26-28 weeks of gestation.\n* Definite and reliable diagnosis of placenta previa (defined as the presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan\n\nExclusion Criteria:\n\n* Multiple pregnancies.\n* Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabour rupture of the membranes (PPROM).\n* Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent -intervention and delivery.\n* Women who have been maintained on progestin therapy since early pregnancy for whatever reason.'}, 'identificationModule': {'nctId': 'NCT03779451', 'briefTitle': 'Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'aswu/191/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '17-OHPC', 'description': "patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery", 'interventionNames': ['Drug: 17-OHPC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vaginal progesterone', 'description': 'vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily at bedtime starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery', 'interventionNames': ['Drug: vaginal progesterone']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone.'}], 'interventions': [{'name': '17-OHPC', 'type': 'DRUG', 'otherNames': ['Active Comparator', 'cidolut depot'], 'description': "received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery.", 'armGroupLabels': ['17-OHPC']}, {'name': 'vaginal progesterone', 'type': 'DRUG', 'otherNames': ['Active Comparator', 'Cyclogest'], 'description': 'vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery', 'armGroupLabels': ['vaginal progesterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'hany f sallam, md', 'role': 'CONTACT', 'email': 'nahla.elsayed@aswu.ed.eg', 'phone': '01092440504', 'phoneExt': '002'}, {'name': 'Nahla w Shady, md', 'role': 'CONTACT', 'email': 'nahla.elsayed@aswu.edu.eg', 'phone': '1019240504', 'phoneExt': '002'}], 'facility': 'Aswan University', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'centralContacts': [{'name': 'hany f sallam, md', 'role': 'CONTACT', 'email': 'hany.farouk@aswu.edu.eg', 'phone': '01022336052', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'hany f sallam, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aswan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}