Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT03730220
Status:
COMPLETED
Last Update Posted:
2019-03-19
First Post:
2018-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Norwegian Induction Project: a Pilot for a Prospective National Audit
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': 1846}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-17', 'studyFirstSubmitDate': '2018-08-21', 'studyFirstSubmitQcDate': '2018-11-02', 'lastUpdatePostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caesarean rate', 'timeFrame': 'Throughout the study period of 3 months', 'description': 'Caesarean rate in induced women'}], 'secondaryOutcomes': [{'measure': 'Time from induction to delivery', 'timeFrame': 'From start of medication/balloon until time of birth of baby', 'description': 'Time from induction initiation to delivery of baby in minutes'}, {'measure': 'Composite infant outcome', 'timeFrame': 'From time of delivery until time of discharge of patient from maternity unit', 'description': 'Low Apgar score and/or transfer to NICU and/or low pH in umbilical artery'}, {'measure': 'Uterine tachysystole during labour', 'timeFrame': 'From start of labour as defined by opening of partograph until time of birth of baby', 'description': 'More than 5 contractions each 10 minutes and fetal tracing abnormality'}, {'measure': 'Indication for induction of labour', 'timeFrame': 'Throughout the study period of 3 months', 'description': 'Proportions of main indications for labour induction'}, {'measure': 'Induction method used', 'timeFrame': 'Throughout the study period of 3 months', 'description': 'Proportions of different induction methods/protocols used'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Induced; Birth', 'Delivery Complication', 'Indications for Care in Pregnancy; Labor; and Delivery']}, 'descriptionModule': {'briefSummary': 'The worldwide rate of induction of labour has been steadily increasing over the last 15 years, a trend that is reflected in Norway.\n\nThe overall aim of this study is to identify disparities between delivery departments in Norway in regards to:\n\n1. The overall rate of labour induction\n2. Main indication for the induction of labour.\n3. Induction methods used and protocols followed\n4. Maternal and fetal outcomes in induced births\n\nMethods:\n\nObservational study. Registration of induction indication, methods and outcomes in induced women. Data will be collected prospectively during a period of 4 months from 21 Norwegian delivery units using a web-based standardized case record form.', 'detailedDescription': "In 2000 the Norwegian national induction rate was 8.8% of all births, but this increased to 21.8% in 2016. The regional induction rate varies between counties, varying from 17.7% of all births in Nordland to 24.0% in Rogaland. Individual units could have an even wider variation. There are reports of a high rate of induction in primiparous women. In some units, local audits have noted that in 2016, over 27% of primiparous women had their labour induced. Labour inductions in primiparous women (Robson group 2a) may be associated with an increased likelihood of caesarean sections and operative vaginal delivery. An increased caesarean rate in primiparous women will have implications for subsequent pregnancies. In Hammerfest Hospital, the caesarean section rate in Robson group 2a was 37% in 2016.\n\nIn Norway, induction of labour is offered in approximately 50 obstetric units. There are national guidelines available for the induction of labour from the Norwegian Gynaecological Society and from the Department of Health. , These guidelines are not categorical and leave the decision for the specific method, or regimen for labour induction, up to the attending gynaecologist or local departments. Thus, the national protocols between departments vary considerably and women living in different regions of Norway do not have the same options for induction of labour.\n\nThe Norwegian situation reflects the international situation where multiple induction protocols exist. There is no consensus regarding the medical criteria for the identification of women for induction of labour, nor the induction methods or protocols used.\n\nAim\n\nThe overall aim of this study is to identify disparities between delivery departments in Norway in regards to:\n\n1. The overall rate of labour induction\n2. Main indication for the induction of labour.\n3. Induction methods used and protocols followed\n4. Maternal and fetal outcomes in induced births\n\nMethods:\n\nObservational study where we perform a prospective registration of induction indication, methods and outcomes in induced women on a common internet platform electronic case record form (e-CRF) through Service For Sensitive Data/Tjeneste For Sensitive Data (TSD), University of Oslo (UiO).\n\nParticipating centres\n\n1. AHUS\n2. Arendal\n3. Bærum\n4. Drammen\n5. Førde\n6. Gjøvik\n7. Haugesund\n8. Hammerfest\n9. Haukeland\n10. Levanger\n11. Lillehammer\n12. Nordland Sentralsykehus\n13. OUS Ullevål\n14. OUS Rikshospitalet\n15. Sykehuset i Vestfold\n16. Sykehuset i Telemark\n17. Tromsø\n18. Trondheim\n19. Kristiansand\n20. Stavanger\n21. Sykehuset Østfold, Kalnes\n22. Ålesund\n\nData registration and project management :\n\nEstablishing an e-CRF at Service For Sensitive Data/Tjeneste For Sensitive Data (TSD) University of Oslo (UiO) (which each participating centre can access online to register variables. Project leader will apply for ethics permission from the Regional Ethics Committee. Each participating centre will apply for database permission from the local Protector of Patient Records (Personvernansvarlig).\n\nEthical considerations:\n\nThe individual health staff responsible for patient care will provide information about the study in Norwegian and English following the medical decision (that is taken independent of this study) to induce the patient. The patient has the right to refuse participation in the study.\n\nProject committee:\n\nIngvil Krarup Sørbye, Kevin Sunde Oppegaard, Anne Flem Jacobsen\n\nInternational advisor: Professor Andrew D. Weeks, Department of Women's and Children's Health, Liverpool Women's Hospital, University of Liverpool, Crown Street, Liverpool, L8 7SS, UK."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Delivery units in Norway with a yearly number of births of \\>1000, or delivery units with \\<1000 births per year, but with a selected birthing population', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Induced women with no previous vaginal delivery\n* Gestational age from 23+0 weeks\n* Viable pregnancy at time of inclusion\n\nExclusion Criteria:\n\n* Previous vaginal delivery'}, 'identificationModule': {'nctId': 'NCT03730220', 'briefTitle': 'The Norwegian Induction Project: a Pilot for a Prospective National Audit', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Induction of Labour in Norway: a Pilot for a Prospective National Audit', 'orgStudyIdInfo': {'id': '2018/1087'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Induction of labour'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Kevin S Oppegaard, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helse Nord, Hammerfest Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '31.12.2020-31.12.2025', 'ipdSharing': 'YES', 'description': 'Individual participant data will not be available for sharing. Only aggregated data in the results will be made available. The Study Protocol, Statistical Analysis Plan, Patient Information Form and results will be made available. The results will be made available immediately following publication, with anyone who wishes to access the data. Proposals may be submitted up to 31.12.2025 following article publication.', 'accessCriteria': 'Personal application'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Akershus', 'class': 'OTHER'}, {'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}, {'name': 'Førde Central Hospital', 'class': 'OTHER'}, {'name': 'Sykehuset Innlandet HF', 'class': 'OTHER'}, {'name': 'Helse Fonna', 'class': 'OTHER'}, {'name': 'Helse Nord', 'class': 'INDUSTRY'}, {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}, {'name': 'Nordlandssykehuset HF', 'class': 'OTHER'}, {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, {'name': 'Sykehuset Telemark', 'class': 'OTHER_GOV'}, {'name': 'Sykehuset i Vestfold HF', 'class': 'OTHER'}, {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, {'name': 'Sykehuset Ostfold', 'class': 'OTHER'}, {'name': 'Helse Møre og Romsdal HF', 'class': 'OTHER_GOV'}, {'name': "Liverpool Women's NHS Foundation Trust", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Ingvil Krarup Sørbye', 'investigatorAffiliation': 'Oslo University Hospital'}}}}