Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-29 @ 11:38 PM
Study NCT ID:
NCT03591159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2018-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Membrane Sweeping on the Delivery Time and the Need of Induction in Term Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 256}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-30', 'studyFirstSubmitDate': '2018-06-19', 'studyFirstSubmitQcDate': '2018-07-08', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need of Labor Induction.', 'timeFrame': 'During pregnancy. 40 weeks and 6 days for gestational age', 'description': "Patient need induction for delivery or not. If the patient reach 40 weeks 6 days for gestational age and spontaneous delivery doesn't begin spontaneously, labor induction is needed."}, {'measure': 'Duration of delivery', 'timeFrame': 'During delivery', 'description': 'The time of the latent and active stage of delivery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delivery, Obstetric']}, 'descriptionModule': {'briefSummary': 'Pregnancies that extend beyond 42 weeks of gestation are at an increased risk for poor fetal and maternal outcomes. For decreasing the number of these cases, some labor induction techniques are used. The status of the cervix is an indicator for the success of the induction. In these study, investigators investigate the effect of membrane sweeping on the need of induction and the delivery time in term pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-35 years\n* Vertex presentation\n* No contraindication for vaginal delivery\n* No contraindication for labor induction\n\nExclusion Criteria:\n\n* Active vaginal infection\n* Previous uterine surgery\n* Systemic disease\n* Multiple pregnancy\n* Fetal anomaly and suspicious fetal health status'}, 'identificationModule': {'nctId': 'NCT03591159', 'briefTitle': 'The Effect of Membrane Sweeping on the Delivery Time and the Need of Induction in Term Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'The Effect of Membrane Sweeping on the Delivery Time and the Need of Induction in Term Pregnancy', 'orgStudyIdInfo': {'id': '09-604-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Membrane Sweeping Group', 'interventionNames': ['Other: Membran Sweeping']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Membran Sweeping', 'type': 'OTHER', 'description': 'Cervical Membrane Sweeping by digital examination', 'armGroupLabels': ['Membrane Sweeping Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06590', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University School of Medicine Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'At the end of the study, participant data access is possible by online.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. Principal Investigator', 'investigatorFullName': 'Batuhan Turgay', 'investigatorAffiliation': 'Ankara University'}}}}