Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-26 @ 2:48 PM
Study NCT ID:
NCT03781466
Status:
UNKNOWN
Last Update Posted:
2019-02-15
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix
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': 'D023802', 'term': 'Cerclage, Cervical'}], 'ancestors': [{'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'A randomized clinical trial open label'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preterm labor before 34 weeks', 'timeFrame': 'Up to 34 weeks gestational age', 'description': 'Number of patients with preterm birth before 34 weeks gestations'}], 'secondaryOutcomes': [{'measure': 'Neonatal respiratory distress syndrome', 'timeFrame': 'At birth', 'description': 'number of neonatal respiratory distress syndrome'}, {'measure': 'Early neonatal death', 'timeFrame': 'within one month postpartum', 'description': 'number babies died in the neonatal period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preterm birth', 'Twin gestation', 'Vaginal progesterone', 'cervical cerclage'], 'conditions': ['Twin; Pregnancy, Affecting Fetus or Newborn']}, 'descriptionModule': {'briefSummary': 'The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.', 'detailedDescription': 'There is a lack of effective, evidence-based interventions for the prevention of preterm birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and cervical cerclage, and the cervical pessary is currently only used within a research setting. There are no reported trials comparing the effectiveness of each of these interventions against each other, whether in isolation or in combination. Research is needed to further evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of women with a short cervix. A recent article by Stock et al.concludes by advising clinicians to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and offer the opportunity to participate in clinical trials. So the objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women pregnant in dichorionic twins', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women pregnant in dichorionic twins.\n* Transvaginal sonographic cervical length is \\<25 mm at 16-20 weeks gestational age.\n* No symptoms, signs or other risk factors for preterm labor\n\nExclusion Criteria:\n\n* Age \\< 18 years or \\> 45 years.\n* Known allergy or contraindication (relative or absolute) to progesterone therapy.\n* Monochorionic twins.\n* Known major fetal structural or chromosomal abnormality.\n* Intrauterine death of one fetus or death of both fetuses.\n* Fetal reduction in the current pregnancy.\n* Medical conditions that may lead to preterm delivery.\n* Rupture of membranes.\n* Vaginal bleeding'}, 'identificationModule': {'nctId': 'NCT03781466', 'briefTitle': 'Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Effect of Cervical Cerclage With or Without Vaginal Progesterone Versus Vaginal Progesterone Alone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'aswu/190/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cervical cerclage', 'description': 'Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm', 'interventionNames': ['Procedure: Cervical cerclage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vaginal progesterone', 'description': 'Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks', 'interventionNames': ['Drug: vaginal progesterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cervical cerclage plus vaginal progesterone', 'description': 'Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm plus Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks', 'interventionNames': ['Procedure: Cervical cerclage', 'Drug: vaginal progesterone']}], 'interventions': [{'name': 'Cervical cerclage', 'type': 'PROCEDURE', 'otherNames': ['Active Comparator'], 'description': 'Cervical cerclage indicated by short cervix ≤25mm', 'armGroupLabels': ['Cervical cerclage', 'Cervical cerclage plus vaginal progesterone']}, {'name': 'vaginal progesterone', 'type': 'DRUG', 'otherNames': ['Active Comparator'], 'description': 'Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks', 'armGroupLabels': ['Cervical cerclage plus vaginal progesterone', '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'}}}}