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

Induced; Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730220
• Other study ID #: 2018/1087
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1846
• Est. completion date: February 28, 2019
• Est. primary completion date: December 31, 2018
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (18)

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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caesarean rate	Caesarean rate in induced women	Throughout the study period of 3 months
Secondary	Time from induction to delivery	Time from induction initiation to delivery of baby in minutes	From start of medication/balloon until time of birth of baby
Secondary	Composite infant outcome	Low Apgar score and/or transfer to NICU and/or low pH in umbilical artery	From time of delivery until time of discharge of patient from maternity unit
Secondary	Uterine tachysystole during labour	More than 5 contractions each 10 minutes and fetal tracing abnormality	From start of labour as defined by opening of partograph until time of birth of baby
Secondary	Indication for induction of labour	Proportions of main indications for labour induction	Throughout the study period of 3 months
Secondary	Induction method used	Proportions of different induction methods/protocols used	Throughout the study period of 3 months