Induced; Birth Clinical Trial
Official title:
Induction of Labour in Norway: a Pilot for a Prospective National Audit
The worldwide rate of induction of labour has been steadily increasing over the last 15
years, a trend that is reflected in Norway.
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.
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.
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.
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