Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT03400358
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
2018-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Uterocervical Angle in the Pregnancy Termination of Multiparous Women
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': 148}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-03', 'studyFirstSubmitDate': '2018-01-06', 'studyFirstSubmitQcDate': '2018-01-12', 'lastUpdatePostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'uterocervical angle', 'timeFrame': '1 week', 'description': 'the angle between the cervical canal and anterior uterine wall'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['uterocervical angle', 'multiparous'], 'conditions': ['Medical; Abortion, Fetus', 'Second Trimester Abortion']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/28055026', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the uterocervical angle (UCA) in the prediction of second trimester termination success of multiparous women.', 'detailedDescription': 'Medical termination of pregnancy is a common procedure in obstetrics. In recent years, uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor. Dziadosz et al concluded that the performance of UCA was even better than the cervical length in their cohort. A wide UCA during second trimester shown to have an increased risk of preterm labor and narrow angle was less likely to have labor.\n\nThe investigators are aimed to investigate predictive role of both cervical length and UCA in the termination of second trimester pregnancy.The investigators focused on multiparous women who are taking Foley baloon for the cervical preparation and aim to measure their UCA.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Multiparous pregnant women undergoing medical abortion in the second trimester', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* multiparous singleton pregnancy\n* no previous systemic illnesses\n\nExclusion Criteria:\n\n* abnormal Pap smear\n* history of dilatation and curettage (D\\&C)\n* history of LEEP and cervical conization'}, 'identificationModule': {'nctId': 'NCT03400358', 'briefTitle': 'Uterocervical Angle in the Pregnancy Termination of Multiparous Women', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Uterocervical Angle in the Termination of Second Trimester Pregnancy in Multiparous Women', 'orgStudyIdInfo': {'id': '2016/12.5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medical abortion', 'description': '150 singleton multiparous patients are planning to complete the study period. Study group constitute of second trimester pregnancies between 14-24 weeks of gestation. All participants were multiparous and had no systemic illnesses. The uterocervical angle will be measured in all participants before the induction of labor.', 'interventionNames': ['Other: uterocervical angle']}], 'interventions': [{'name': 'uterocervical angle', 'type': 'OTHER', 'description': 'the angle between cervical canal and anterior uterine wall is measured sonographically.', 'armGroupLabels': ['Medical abortion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni SSTRH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md, ObGYN', 'investigatorFullName': 'Berna Aslan Cetin', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}