Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-27 @ 3:13 AM
Study NCT ID:
NCT02928302
Status:
WITHDRAWN
Last Update Posted:
2018-11-19
First Post:
2016-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'new protocol started 31/18', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-15', 'studyFirstSubmitDate': '2016-10-06', 'studyFirstSubmitQcDate': '2016-10-06', 'lastUpdatePostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'preterm birth rate', 'timeFrame': 'Less than 37 weeks', 'description': 'either spontaneous or indicated preterm delivery'}], 'secondaryOutcomes': [{'measure': 'Perinatal death', 'timeFrame': 'Between birth and 28 days of age', 'description': 'either neonatal death or fetal death'}, {'measure': 'preterm birth rates', 'timeFrame': 'Less than 24, 28, 32, 30, and 34 weeks gestation', 'description': 'either spontaneous or indicated preterm delivery'}, {'measure': 'admission to neonatal intensive care unit', 'timeFrame': 'time of delivery'}, {'measure': 'Composite perinatal outcome', 'timeFrame': 'Between birth and 28 days of age', 'description': 'Includes necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH) (grade 3 or higher), respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), retinopathy (ROP), blood-culture proven sepsis and neonatal death'}, {'measure': 'necrotizing enterocolitis', 'timeFrame': 'Between birth and 28 days of age', 'description': 'Defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation'}, {'measure': 'intraventricular hemorrhage (grade 3 or higher)', 'timeFrame': 'Between birth and 28 days of age', 'description': 'IVH'}, {'measure': 'respiratory distress syndrome', 'timeFrame': 'Time of delivery', 'description': 'Respiratory distress with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates'}, {'measure': 'birth weight', 'timeFrame': 'time of delivery'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Discharge from hospital', 'description': 'Days in NICU'}, {'measure': 'Neonatal death', 'timeFrame': 'Between birth and 28 days of age'}, {'measure': 'gestational age at delivery', 'timeFrame': 'time of delivery'}, {'measure': 'latency', 'timeFrame': 'time of delivery', 'description': 'from randomization to delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Birth']}, 'descriptionModule': {'briefSummary': 'Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations.\n\nHowever, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, we aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy without prior spontaneous PTB'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-50 years of age\n* Singleton pregnancy (limits the participants to female gender)\n* No prior spontaneous preterm delivery, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks\n\nExclusion Criteria:\n\n* Multiple gestation\n* Prior spontaneous preterm birth 16-36 6/7 weeks\n* Ruptured membranes at time of randomization\n* Lethal fetal structural anomaly at time of randomization\n* Fetal chromosomal abnormality at time of randomization\n* Placenta previa and/or accreta at time of randomization\n* Women who already underwent TVU CL measurement during the index pregnancy'}, 'identificationModule': {'nctId': 'NCT02928302', 'briefTitle': 'Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth', 'orgStudyIdInfo': {'id': '254/16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TVU CL screening', 'description': 'TVU CL screening: single TVU CL at 18 0/7 to 23 6/7 every week', 'interventionNames': ['Other: TVU CL screening']}, {'type': 'NO_INTERVENTION', 'label': 'no screening', 'description': 'no TVU CL screening'}], 'interventions': [{'name': 'TVU CL screening', 'type': 'OTHER', 'description': 'Transvaginal ultrasound cervical length screening', 'armGroupLabels': ['TVU CL screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80100', 'city': 'Naples', 'country': 'Italy', 'facility': 'Gabriele Saccone', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Gabriele Saccone', 'investigatorAffiliation': 'Federico II University'}}}}