Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-31 @ 5:38 AM
Study NCT ID:
NCT04013035
Status:
COMPLETED
Last Update Posted:
2019-07-10
First Post:
2019-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Length on Pregnancy Termination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2019-07-07', 'studyFirstSubmitQcDate': '2019-07-07', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cervical length measurement', 'timeFrame': '2 days', 'description': 'cervical length measurement at second trimester pregnancy termination in nulliparous pregnant women. The measurements will be saved as a number in cm.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervix', 'Length', 'Viability', 'prostaglandin', 'Termination'], 'conditions': ['Pregnancy Loss']}, 'descriptionModule': {'briefSummary': 'Cervical length is used as a parameter to predict cervical insufficiency and onset of labor. However, its role in predicting abortion induction is unclear.To investigate the impact of cervical length measurement and fetal viability on second trimester pregnancy termination duration in nulliparous pregnant women.', 'detailedDescription': 'Cervical length and fetal viability were evaluated prior to second trimester pregnancy termination due to various indications. nulliparous pregnant women through 13 and 26 gestational weeks in whom pregnancy termination was conducted within 72 hours after admission were included in the study. The subjects were grouped into two groups according to fetal viability.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nulliparous pregnant women at 13-26 weeks of gestation will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Nulliparous pregnant women at 13-26 weeks of gestation\n\nExclusion Criteria:\n\n* Patients with multiple gestations,\n* multiparous patients or\n* patients that had uterine gynecologic surgery'}, 'identificationModule': {'nctId': 'NCT04013035', 'briefTitle': 'Cervical Length on Pregnancy Termination', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'The Impact of Fetal Viability and Cervical Length on Pregnancy Termination Outcomes in Nulliparous Second Trimester Pregnancies', 'orgStudyIdInfo': {'id': '2015.01.01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cervical length measurement', 'type': 'PROCEDURE', 'description': 'cervical length measurement at second trimester pregnancy termination in nulliparous pregnant women.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33404', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Süleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator, M.D, Department of Obstetrics and Gynecology', 'investigatorFullName': 'Pınar Kadirogulları', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}