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

Study Overview
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Brief Summary
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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: The overall rate of labour induction Main indication for the induction of labour. Induction methods used and protocols followed 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
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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: The overall rate of labour induction Main indication for the induction of labour. Induction methods used and protocols followed 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 AHUS Arendal Bærum Drammen Førde Gjøvik Haugesund Hammerfest Haukeland Levanger Lillehammer Nordland Sentralsykehus OUS Ullevål OUS Rikshospitalet Sykehuset i Vestfold Sykehuset i Telemark Tromsø Trondheim Kristiansand Stavanger Sykehuset Østfold, Kalnes 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.

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

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

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Induction of labour<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caesarean rate | Caesarean rate in induced women | Throughout the study period of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Indication for induction of labour | Proportions of main indications for labour induction | Throughout the study period of 3 months | 
| Induction method used | Proportions of different induction methods/protocols used | Throughout the study period of 3 months |