Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-06 @ 11:19 AM
Study NCT ID:
NCT02911727
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2016-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fast-track Discharge After Elective Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-31', 'studyFirstSubmitDate': '2016-09-02', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Parents' Postnatal Sense of Security", 'timeFrame': 'Measured one week after delivery', 'description': 'Using the validated PPSS-questionaire'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': 'During the first week postpartum', 'description': 'Measured by the patient in a questionnaire using numeric rating scale'}, {'measure': 'Use of analgesia', 'timeFrame': 'During the first week postpartum', 'description': 'Daily consumption in mg of paracetamol, NSAID and opioid.'}, {'measure': 'Mobilization', 'timeFrame': '5 days postpartum', 'description': 'Step count measured by an activity monitor (Fitbit Flex)'}, {'measure': 'Breastfeeding', 'timeFrame': '6 months after delivery', 'description': 'Duration and extent of breastfeeding'}, {'measure': 'Readmissions', 'timeFrame': '28 days postpartum', 'description': 'Number of readmissions and length of hospital stay in number of days'}, {'measure': 'Surgical complications', 'timeFrame': '28 days postpartum', 'description': 'Number of complications using the Clavien-Dindo Classification (1-5)'}, {'measure': 'Complications in the postnatal period', 'timeFrame': '28 days postpartum', 'description': 'Number and type of complications using the ICD-10 classification'}, {'measure': 'Contacts to the health care system', 'timeFrame': '28 days postpartum', 'description': 'Number of contacts and site of contacts (primary or secondary care)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cesarean section', 'Postnatal Care'], 'conditions': ['Postoperative Period']}, 'referencesModule': {'references': [{'pmid': '34100558', 'type': 'DERIVED', 'citation': 'Jones E, Stewart F, Taylor B, Davis PG, Brown SJ. Early postnatal discharge from hospital for healthy mothers and term infants. Cochrane Database Syst Rev. 2021 Jun 8;6(6):CD002958. doi: 10.1002/14651858.CD002958.pub2.'}]}, 'descriptionModule': {'briefSummary': "Cesarean section (CS) is a procedure with prolonged hospital stay compared to the routine for normal vaginal delivery in multiparas. The difference is caused mainly by postoperative pain but improvements in management of pain may change this situation and make early discharge possible. However, several aspects need to be considered.\n\nThe aim of this project is to evaluate fast-track discharge for multiparas after elective CS concerning neonatal and maternal complications as well as the parents' sense of security and well-being.\n\nThe study is a randomized controlled trial including 142 women allocated to either 1) the intention to discharge within 28 hours followed by a home visit or 2) standard discharge after at least 48 hours after elective CS.\n\nThis study will be among the first evaluating fast-track discharge after CS in a European context. If a positive outcome is achieved, we expect that fast-track discharge can be implemented with improved quality and reduced costs in postnatal care following elective CS."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned elective CS of multiparous women\n* Singleton pregnancy\n* Gestational age at least 37+0 weeks\n* Prepregnancy BMI \\<35\n\nExclusion Criteria:\n\n* Lack of consent\n* Women with no or little understanding of and ability to speak Danish\n* Expected maternal or neonatal complications after delivery'}, 'identificationModule': {'nctId': 'NCT02911727', 'briefTitle': 'Fast-track Discharge After Elective Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Herning Hospital'}, 'officialTitle': 'Fast-track Discharge After Elective Cesarean Section', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fast-track discharge', 'description': 'Intention to discharge within 28 hours after elective cesarean section including a home visit by a nurse or midwife from the postnatal ward.', 'interventionNames': ['Procedure: Fast-track discharge']}, {'type': 'NO_INTERVENTION', 'label': 'Standard discharge', 'description': 'Discharge at least 48 hours after elective cesarean section.'}], 'interventions': [{'name': 'Fast-track discharge', 'type': 'PROCEDURE', 'description': 'As described above', 'armGroupLabels': ['Fast-track discharge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Herning', 'country': 'Denmark', 'facility': 'Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'overallOfficials': [{'name': 'Byrjalsen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department chairman'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herning Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Anne Kruse', 'investigatorAffiliation': 'Herning Hospital'}}}}