Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-27 @ 8:16 PM
Study NCT ID:
NCT06357468
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2024-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Pain Management and Pain Perception Intrapartum and Postpartum in Women with Vaginal Births in Difference Between Physician-led and Midwife-led Birth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011247', 'term': 'Pregnancy'}], 'ancestors': [{'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2024-03-30', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain perception', 'timeFrame': 'intrapartum (start of labour until end of labour) and postpartum first 3 days after birth', 'description': 'Measured by visual pain scale (1-10)'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with pain therapy', 'timeFrame': 'intrapartum (start of labour until end of labour) and postpartum first 3 days after birth', 'description': 'Measured by visual analog scale (1-10)'}, {'measure': 'Pain perception in women with perineal tear grade III', 'timeFrame': 'postpartum first 3 days after birth', 'description': 'Measured by visual pain scale (1-10)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Labor']}, 'descriptionModule': {'briefSummary': 'The aim of the analysis is to describe the differences and similarities in obstetric pain management and pain perception intrapartum and postpartum in women with vaginal births in contrast to physician-led births and midwife-led births'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women under birth', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Understanding written and spoken German\n* Declaration of consent\n\nExclusion Criteria:\n\n* under 18 years\n* incomplete answered questionaire'}, 'identificationModule': {'nctId': 'NCT06357468', 'briefTitle': 'Analysis of Pain Management and Pain Perception Intrapartum and Postpartum in Women with Vaginal Births in Difference Between Physician-led and Midwife-led Birth', 'organization': {'class': 'OTHER', 'fullName': 'Martin-Luther-Universität Halle-Wittenberg'}, 'officialTitle': 'Analysis of Pain Management and Pain Perception Intrapartum and Postpartum in Women with Vaginal Births in Difference Between Physician-led and Midwife-led Birth', 'orgStudyIdInfo': {'id': 'UKGEB003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'physician-led births', 'interventionNames': ['Other: midwife-led births in low risk women in pregnancy']}, {'label': 'midwife-led births'}], 'interventions': [{'name': 'midwife-led births in low risk women in pregnancy', 'type': 'OTHER', 'description': 'Pregnant women in the low-risk collective are cared for in a midwife-led delivery room if they wish to have a natural birth', 'armGroupLabels': ['physician-led births']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06120', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'University Hospital of Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marcus Riemer, MD', 'investigatorAffiliation': 'Martin-Luther-Universität Halle-Wittenberg'}}}}