CClinicalTrials.gg
CompletedNCT03730220Updated Mar 19, 2019

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

An observational study in Induced; Birth, Delivery Complication and Indications for Care in Pregnancy; Labor; and Delivery, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to female participants. Per ClinicalTrials.gov, last updated 2019-03-19.

Sponsored by Oslo University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,846
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Induced; Birth
  • Delivery Complication
  • Indications for Care in Pregnancy; Labor; and Delivery
03

In context

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous vaginal delivery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,846 participants (actual)
Patient registry
No

Groups and cohorts

  • Induction of labour
06

What researchers measure

Primary outcomes

  1. Caesarean rate

    Caesarean rate in induced women

    Time frame: Throughout the study period of 3 months

Secondary outcomes

  1. Time from induction to delivery

    Time from induction initiation to delivery of baby in minutes

    Time frame: From start of medication/balloon until time of birth of baby

  2. Composite infant outcome

    Low Apgar score and/or transfer to NICU and/or low pH in umbilical artery

    Time frame: From time of delivery until time of discharge of patient from maternity unit

  3. Uterine tachysystole during labour

    More than 5 contractions each 10 minutes and fetal tracing abnormality

    Time frame: From start of labour as defined by opening of partograph until time of birth of baby

  4. Indication for induction of labour

    Proportions of main indications for labour induction

    Time frame: Throughout the study period of 3 months

  5. Induction method used

    Proportions of different induction methods/protocols used

    Time frame: Throughout the study period of 3 months

07

Study locations

1 site
  • Oslo University Hospital
    Oslo, 0424, Norway
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03730220
Lead sponsor
Oslo University Hospital
Collaborators
University Hospital, Akershus, Vestre Viken Hospital Trust, Førde Central Hospital, Sykehuset Innlandet HF, Helse Fonna, Helse Nord, Haukeland University Hospital, Helse Nord-Trøndelag HF, Nordlandssykehuset HF, Sorlandet Hospital HF, Sykehuset Telemark, Sykehuset i Vestfold HF, St. Olavs Hospital, Helse Stavanger HF, Sykehuset Ostfold, Helse Møre og Romsdal HF, Liverpool Women's NHS Foundation Trust
Responsible party
Ingvil Krarup Sørbye (Consultant, Oslo University Hospital) — Principal investigator
First posted
Nov 5, 2018
Start date
Sep 1, 2018
Primary completion
Dec 31, 2018
Completion
Feb 28, 2019
Last update
Mar 19, 2019

Study contacts

Kevin S Oppegaard, PhD, MD
study director · Helse Nord, Hammerfest Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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