Skip to content

The Norwegian Induction Project: a Pilot for a Prospective National Audit

Induction of Labour in Norway: a Pilot for a Prospective National Audit

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03730220
Enrollment
1846
Registered
2018-11-05
Start date
2018-09-01
Completion date
2019-02-28
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery Complication, Indications for Care in Pregnancy; Labor; and Delivery, Induced; Birth

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

University Hospital, Akershus
CollaboratorOTHER
Vestre Viken Hospital Trust
CollaboratorOTHER
Førde Central Hospital
CollaboratorOTHER
Sykehuset Innlandet HF
CollaboratorOTHER
Helse Fonna
CollaboratorOTHER
Helse Nord
CollaboratorINDUSTRY
Haukeland University Hospital
CollaboratorOTHER
Helse Nord-Trøndelag HF
CollaboratorOTHER
Nordlandssykehuset HF
CollaboratorOTHER
Sorlandet Hospital HF
CollaboratorOTHER_GOV
Sykehuset Telemark
CollaboratorOTHER_GOV
Sykehuset i Vestfold HF
CollaboratorOTHER
St. Olavs Hospital
CollaboratorOTHER
Helse Stavanger HF
CollaboratorOTHER_GOV
Sykehuset Ostfold
CollaboratorOTHER
Helse Møre og Romsdal HF
CollaboratorOTHER_GOV
Liverpool Women's NHS Foundation Trust
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE

Inclusion criteria

* Induced women with no previous vaginal delivery * Gestational age from 23+0 weeks * Viable pregnancy at time of inclusion

Exclusion criteria

* Previous vaginal delivery

Design outcomes

Primary

MeasureTime frameDescription
Caesarean rateThroughout the study period of 3 monthsCaesarean rate in induced women

Secondary

MeasureTime frameDescription
Time from induction to deliveryFrom start of medication/balloon until time of birth of babyTime from induction initiation to delivery of baby in minutes
Composite infant outcomeFrom time of delivery until time of discharge of patient from maternity unitLow Apgar score and/or transfer to NICU and/or low pH in umbilical artery
Uterine tachysystole during labourFrom start of labour as defined by opening of partograph until time of birth of babyMore than 5 contractions each 10 minutes and fetal tracing abnormality
Indication for induction of labourThroughout the study period of 3 monthsProportions of main indications for labour induction
Induction method usedThroughout the study period of 3 monthsProportions of different induction methods/protocols used

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026