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

NCT03730220 | Completed

• 1 other identifier: 2018/1087
• Study Type: observational
• Target: 1,846
• Locations: 1 country
• Sites: 1

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. 1.The overall rate of labour induction
2. 2.Main indication for the induction of labour.
3. 3.Induction methods used and protocols followed
4. 4.Maternal and fetal outcomes in induced births

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Caesarean rate

  Caesarean rate in induced women

  Throughout the study period of 3 months

Secondary Outcomes (5)

• Time from induction to delivery

  From start of medication/balloon until time of birth of baby

• Composite infant outcome

  From time of delivery until time of discharge of patient from maternity unit

• Uterine tachysystole during labour

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

• Indication for induction of labour

  Throughout the study period of 3 months

• Induction method used

  Throughout the study period of 3 months

Study Arms (1)

Induction of labour

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Induced women with no previous vaginal delivery
• Gestational age from 23+0 weeks

You may not qualify if:

• Previous vaginal delivery

Sponsors & Collaborators

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

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Study Officials

• Kevin S Oppegaard, PhD, MD

  Helse Nord, Hammerfest Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: November 5, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: February 28, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 31.12.2020-31.12.2025
• Access Criteria: Personal application

Locations

NO (1)