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Completed

NCT Number: NCT03730220

The Norwegian Induction Project: 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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Caesarean rate

    Time frame: Throughout the study period of 3 months

    Caesarean rate in induced women

Secondary outcomes

  1. Time from induction to delivery

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

    Time from induction initiation to delivery of baby in minutes

  2. Composite infant outcome

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

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

  3. Uterine tachysystole during labour

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

    More than 5 contractions each 10 minutes and fetal tracing abnormality

  4. Indication for induction of labour

    Time frame: Throughout the study period of 3 months

    Proportions of main indications for labour induction

  5. Induction method used

    Time frame: Throughout the study period of 3 months

    Proportions of different induction methods/protocols used

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Nov 5, 2018
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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