Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-26 @ 11:08 PM
Study NCT ID:
NCT01424059
Status:
UNKNOWN
Last Update Posted:
2011-08-26
First Post:
2011-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction of Women With Fear of Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-24', 'studyFirstSubmitDate': '2011-08-05', 'studyFirstSubmitQcDate': '2011-08-24', 'lastUpdatePostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'experience of delivery', 'timeFrame': 'Within 48 hours after delivery', 'description': 'Experience of labor is evaluated with a questionnaire (WEDQ-B) within 48 hours'}], 'secondaryOutcomes': [{'measure': 'Operative delivery', 'timeFrame': 'within 48 hours', 'description': 'within 48 hours from inclusion in the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fear', 'labor', 'induction', 'amniotomy', 'WEDQ-B', 'parous', 'cesarean section'], 'conditions': ['Fear']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the experience of labor in parous women induced because of fear of labor and, to compare the experience of parous women induced without fear of labor. A comparison with the experience of women delivered with elective cesarean section because of fear of labor is done.\n\nIn the induced labors, the induction method is amniotomy. Between groups the experience of delivery is evaluated with a questionnaire: Wijma Delivery Expectancy Questionnaire(WEDQ-B).\n\nGroups are also compared with regard to time from induction to delivery and rate of operative delivery.\n\nHypotheses:\n\n* there is no difference in experience of delivery\n* there is no difference in time to delivery or rate of operative deliveries'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parous women with cercvical status allowing amniotomy as method for induction. Parous women planned for cesarean section.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parous\n* induction or cesarean section\n* amniotomy\n\nExclusion Criteria:\n\n* non proficiency in the Swedish language'}, 'identificationModule': {'nctId': 'NCT01424059', 'briefTitle': 'Induction of Women With Fear of Labor', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University Hospital'}, 'officialTitle': 'Planned Induction of Women With Fear of Labor and Evaluation of the Experience of Delivery', 'orgStudyIdInfo': {'id': 'UAS-11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'fear of labor', 'description': 'Parous women with fear of labor', 'interventionNames': ['Other: WEDQ-B (questionnaire)']}], 'interventions': [{'name': 'WEDQ-B (questionnaire)', 'type': 'OTHER', 'description': 'Questionnaires are answered after delivery; within 48 hours and after five weeks', 'armGroupLabels': ['fear of labor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '751 85', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Maria Jonsson, M.D., Ph.D', 'role': 'CONTACT', 'phone': '+466110000'}], 'facility': 'Department of Obstetrics and Gynecology, Akademiska hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D. Consultant', 'investigatorFullName': 'Maria Jonsson', 'investigatorAffiliation': 'Uppsala University Hospital'}}}}