Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT00694967
Status:
TERMINATED
Last Update Posted:
2008-06-11
First Post:
2008-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077713', 'term': '17 alpha-Hydroxyprogesterone Caproate'}], 'ancestors': [{'id': 'D019326', 'term': '17-alpha-Hydroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'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': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'whyStopped': 'Interim analysis showed no difference in outcome between treatment groups.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-07', 'studyFirstSubmitDate': '2008-06-07', 'studyFirstSubmitQcDate': '2008-06-07', 'lastUpdatePostDateStruct': {'date': '2008-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome was spontaneous preterm birth prior to 35 weeks gestation', 'timeFrame': '11/2003 - 12/2006'}], 'secondaryOutcomes': [{'measure': 'Obstetrical complications', 'timeFrame': '11/2003 - 12/2006'}, {'measure': 'Neonatal morbidity & mortality', 'timeFrame': '11/2003 --12/2006'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['short cervix, cervical funneling, spontaneous preterm birth, cerclage, progesterone'], 'conditions': ['Mid Trimester Cervical Shortening']}, 'descriptionModule': {'briefSummary': 'We hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17P) will reduce the number spontaneous preterm births prior to 35 weeks gestation when compared to cerclage therapy. The purpose of this study was to compare medical therapy with 17P to surgical therapy with transvaginal cerclage in patients with an ultrasound diagnosed short cervix and funnel in the mid-trimester.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ultrasonographic evidence of premature dilatation of the internal os\n* Prolapse of the chorio-amniotic membranes into the endocervical canal\n* Functional cervical length less than 25mm\n* Exacerbation of these ultrasound findings with transfundal and/or suprapubic pressure\n\nExclusion Criteria:\n\n* Any fetal chromosomal or structural anomaly\n* Multiple gestation\n* Known allergy to progesterone\n* Ruptured membranes\n* Vaginal bleeding\n* Intra-amniotic infection (diagnosed clinically or by amniocentesis)\n* Prolapse of endocervical membranes beyond the external cervical os\n* Persistent uterine activity accompanied by cervical change\n* Obstetrically indicated delivery.'}, 'identificationModule': {'nctId': 'NCT00694967', 'briefTitle': 'A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix', 'organization': {'class': 'OTHER', 'fullName': 'Lehigh Valley Hospital'}, 'officialTitle': 'Histologic Evaluation of the Cervix at Risk for Preterm Birth Trial:Medical Versus Surgical Therapy', 'orgStudyIdInfo': {'id': '2003103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'McDonald cerclage', 'interventionNames': ['Procedure: McDonald cerclage placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '17 hydroxyprogesterone caproate', 'interventionNames': ['Drug: 17 hydroxyprogesterone caproate']}], 'interventions': [{'name': 'McDonald cerclage placement', 'type': 'PROCEDURE', 'description': 'Transcervical McDonald cerclage placement', 'armGroupLabels': ['1']}, {'name': '17 hydroxyprogesterone caproate', 'type': 'DRUG', 'description': 'Weekly 250mg intramuscular injections', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18105', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Hospital', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}], 'overallOfficials': [{'name': 'Orion Rust, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lehigh Valley Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lehigh Valley Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Orion Rust M.D.', 'oldOrganization': 'Lehigh Valley Hospital'}}}}