The Norwegian Induction Project: a Pilot for a Prospective National Audit
NCT ID: NCT03730220
Last Updated: 2019-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1846 participants
OBSERVATIONAL
2018-09-01
2019-02-28
Brief Summary
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The overall aim of this study is to identify disparities between delivery departments in Norway in regards to:
1. The overall rate of labour induction
2. Main indication for the induction of labour.
3. Induction methods used and protocols followed
4. Maternal and fetal outcomes in induced births
Methods:
Observational 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.
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Detailed Description
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In 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.
The 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.
Aim
The overall aim of this study is to identify disparities between delivery departments in Norway in regards to:
1. The overall rate of labour induction
2. Main indication for the induction of labour.
3. Induction methods used and protocols followed
4. Maternal and fetal outcomes in induced births
Methods:
Observational 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).
Participating centres
1. AHUS
2. Arendal
3. Bærum
4. Drammen
5. Førde
6. Gjøvik
7. Haugesund
8. Hammerfest
9. Haukeland
10. Levanger
11. Lillehammer
12. Nordland Sentralsykehus
13. OUS Ullevål
14. OUS Rikshospitalet
15. Sykehuset i Vestfold
16. Sykehuset i Telemark
17. Tromsø
18. Trondheim
19. Kristiansand
20. Stavanger
21. Sykehuset Østfold, Kalnes
22. Ålesund
Data registration and project management :
Establishing 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).
Ethical considerations:
The 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.
Project committee:
Ingvil Krarup Sørbye, Kevin Sunde Oppegaard, Anne Flem Jacobsen
International 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Induction of labour
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Gestational age from 23+0 weeks
* Viable pregnancy at time of inclusion
Exclusion Criteria
FEMALE
No
Sponsors
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University Hospital, Akershus
OTHER
Vestre Viken Hospital Trust
OTHER
Førde Central Hospital
OTHER
Sykehuset Innlandet HF
OTHER
Helse Fonna
OTHER
Helse Nord
INDUSTRY
Haukeland University Hospital
OTHER
Helse Nord-Trøndelag HF
OTHER
Nordlandssykehuset HF
OTHER
Sorlandet Hospital HF
OTHER_GOV
Sykehuset Telemark
OTHER_GOV
Sykehuset i Vestfold HF
OTHER
St. Olavs Hospital
OTHER
Helse Stavanger HF
OTHER_GOV
Sykehuset Ostfold
OTHER
Helse Møre og Romsdal HF
OTHER_GOV
Liverpool Women's NHS Foundation Trust
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Ingvil Krarup Sørbye
Consultant
Principal Investigators
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Kevin S Oppegaard, PhD, MD
Role: STUDY_DIRECTOR
Helse Nord, Hammerfest Hospital
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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Other Identifiers
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2018/1087
Identifier Type: -
Identifier Source: org_study_id
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