Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-02-24 @ 8:27 AM
Study NCT ID:
NCT02673359
Status:
UNKNOWN
Last Update Posted:
2023-04-10
First Post:
2016-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D023802', 'term': 'Cerclage, Cervical'}], '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'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2016-02-01', 'studyFirstSubmitQcDate': '2016-02-01', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preterm labor before 35 weeks', 'timeFrame': 'Up to 35 weeks gestational age'}], 'secondaryOutcomes': [{'measure': 'Delivery before 37 weeks', 'timeFrame': 'Up to 37 weeks gestational age'}, {'measure': 'Low birth weight (LBW)', 'timeFrame': 'At birth', 'description': 'Birth weight of a living neonate of \\< 2500 gm regardless of gestational age'}, {'measure': 'Neonatal respiratory distress syndrome (RDS)', 'timeFrame': 'At birth'}, {'measure': 'Early neonatal death (END)', 'timeFrame': 'One month after birth'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preterm labor', 'Short cervix', 'Progesterone', 'Cervical cerclage'], 'conditions': ['Premature Labour']}, 'descriptionModule': {'briefSummary': 'The aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor.', 'detailedDescription': 'Women with singleton pregnancy and history of preterm labor and/or midtrimester miscarriage in a previous pregnancy will be selected for serial assessment of the cervical length by transvaginal sonography (TVS) starting from 16 weeks till 24 weeks of gestation. Eligible participants in our study will be those who have cervical length of 15-25 mm at 16-24 weeks of gestation. At 16-24 weeks gestational age, all women participating in the study will be randomly allocated into two groups; progesterone group and cerclage group. For women in the progesterone group, vaginal progesterone suppositories will be given in a dose of 400 mg/day. For women in the cerclage group, McDonald cervical cerclage will be performed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with singleton pregnancy.\n* History of preterm labor and/or midtrimester miscarriage in a previous pregnancy.\n* Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation.\n\nExclusion Criteria:\n\n* Age \\< 20 or \\> 35 years.\n* Congenital uterine malformation.\n* Multifetal pregnancy.\n* Known major fetal structural or chromosomal abnormality.\n* Known allergy or contraindication (relative or absolute) to progesterone therapy.\n* Presence of contraindication to cervical cerclage.\n* Medical conditions complicating pregnancy.\n* Vaginal bleeding.'}, 'identificationModule': {'nctId': 'NCT02673359', 'briefTitle': 'Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Sonographic Short Cervix and History of Preterm Labor and/or Midtrimester Miscarriage', 'orgStudyIdInfo': {'id': 'WR2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Progesterone group', 'description': 'Vaginal progesterone suppositories will be given', 'interventionNames': ['Drug: Progesterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cerclage group', 'description': 'Cervical cerclage will be performed.', 'interventionNames': ['Procedure: Cervical cerclage']}], 'interventions': [{'name': 'Progesterone', 'type': 'DRUG', 'otherNames': ['Cyclogest', 'Prontogest'], 'description': 'Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day', 'armGroupLabels': ['Progesterone group']}, {'name': 'Cervical cerclage', 'type': 'PROCEDURE', 'otherNames': ['Cervical stitch'], 'description': 'Cervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage)', 'armGroupLabels': ['Cerclage group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Obstetrics and Gynecology Department in Mansoura University Hospital', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Private practice settings', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'city': 'Port Said', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Obstetrics and Gynecology Department in Port Said University', 'geoPoint': {'lat': 31.26531, 'lon': 32.3019}}], 'centralContacts': [{'name': 'Waleed El-refaie, Dr', 'role': 'CONTACT', 'email': 'wrefaie@yahoo.com'}], 'overallOfficials': [{'name': 'Waleed El-refaie, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Port Said University'}, {'name': 'Mohamed S Abdelhafez, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}, {'name': 'Ahmed M Badawy, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Sayed Abdelhafez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohamed Sayed Abdelhafez', 'investigatorAffiliation': 'Mansoura University'}}}}