Induced; BirthNCT03730220
The Norwegian Induction Project: a Pilot for a Prospective National Audit
An observational study of Induced; Birth and Delivery Complication, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Induced; Birth, Delivery Complication, Indications for Care in Pregnancy; Labor; and Delivery
- How many people
- 1,846 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2018to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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
Who may be able to join
- Induced women with no previous vaginal delivery
- Gestational age from 23+0 weeks
- Viable pregnancy at time of inclusion
Who cannot join
- Previous vaginal delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Induction of Labour in Norway: 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:
- 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.
Read the detailed 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:
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Induction of labour | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean rate
Caesarean rate in induced women
Measured: Throughout the study period of 3 months
Secondary outcomes (5)
Time from induction to delivery
Time from induction initiation to delivery of baby in minutes
Measured: 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
Measured: 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
Measured: 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
Measured: Throughout the study period of 3 months
Induction method used
Proportions of different induction methods/protocols used
Measured: Throughout the study period of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced; BirthStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus, Vestre Viken Hospital Trust, Førde Central Hospital, Sykehuset Innlandet HF, Helse Fonna, Helse Nord, Haukeland University Hospital, Helse Nord-Trøndelag HF, 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
- Responsible party
- Principal investigator, Ingvil Krarup Sørbye, Oslo University Hospital
- Investigators
- Kevin S Oppegaard, PhD, MD, Study director, Helse Nord, Hammerfest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730220
- Sponsor's protocol ID
- 2018/1087
- Status last verified
- Mar 2019
- First submitted
- 21 Aug 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labour in Norway: a Pilot for a Prospective National Audit
- ClinicalTrials.gov ID
- NCT03730220
- Acronym / sponsor ID
- 2018/1087
- Conditions
- Induced; Birth, Delivery Complication, Indications for Care in Pregnancy; Labor; and Delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,846 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus, Vestre Viken Hospital Trust, Førde Central Hospital, Sykehuset Innlandet HF, Helse Fonna, Helse Nord, Haukeland University Hospital, Helse Nord-Trøndelag HF, 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
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction of labour | – | – |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Induced women with no previous vaginal delivery
- Gestational age from 23+0 weeks
- Viable pregnancy at time of inclusion
Key exclusion criteria (1 listed)
- Previous vaginal delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Caesarean rate
Time frame: Throughout the study period of 3 months
Caesarean rate in induced women
5 secondary outcomes
Time from induction to delivery
Time frame: From start of medication/balloon until time of birth of baby
Composite infant outcome
Time frame: From time of delivery until time of discharge of patient from maternity unit
Uterine tachysystole during labour
Time frame: From start of labour as defined by opening of partograph until time of birth of baby
Indication for induction of labour
Time frame: Throughout the study period of 3 months
Induction method used
Time frame: Throughout the study period of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin S Oppegaard, PhD, MD study director
Helse Nord, Hammerfest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Induced; Birth and Delivery Complication, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caesarean rate (time frame: Throughout the study period of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.