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

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ClinicalTrials.gov Identifier: NCT03730220
Recruitment Status : Completed
First Posted : November 5, 2018
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
University Hospital, Akershus
Vestre Viken Hospital Trust
Førde Central Hospital
Sykehuset Innlandet HF
Helse Fonna
Helse Nord
Haukeland University Hospital
Levanger Hospital
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
Information provided by (Responsible Party):
Ingvil Krarup Sørbye, Oslo University Hospital

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. 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.


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

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 1846 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Induction of Labour in Norway: a Pilot for a Prospective National Audit
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : February 28, 2019

Group/Cohort
Induction of labour



Primary Outcome Measures :
  1. Caesarean rate [ Time Frame: Throughout the study period of 3 months ]
    Caesarean rate in induced women


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730220


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
Vestre Viken Hospital Trust
Førde Central Hospital
Sykehuset Innlandet HF
Helse Fonna
Helse Nord
Haukeland University Hospital
Levanger Hospital
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
Investigators
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Study Director: Kevin S Oppegaard, PhD, MD Helse Nord, Hammerfest Hospital

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Responsible Party: Ingvil Krarup Sørbye, Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03730220     History of Changes
Other Study ID Numbers: 2018/1087
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 31.12.2020-31.12.2025
Access Criteria: Personal application

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No