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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Norway1 site
  • Oslo University Hospital

    Oslo, 0424

Other trials in Norway

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:

  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.

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:

  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 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

  1. AHUS
  2. Arendal
  3. Bærum
  4. Drammen
  5. Førde
  6. Gjøvik
  7. Haugesund
  8. Hammerfest
  9. Haukeland
  10. Levanger
  11. Lillehammer
  12. Nordland Sentralsykehus
  13. OUS Ullevål
  14. OUS Rikshospitalet
  15. Sykehuset i Vestfold
  16. Sykehuset i Telemark
  17. Tromsø
  18. Trondheim
  19. Kristiansand
  20. Stavanger
  21. Sykehuset Østfold, Kalnes
  22. 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 groups in NCT03730220
Study groupRoleWhat they receive
Induction of labourNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Caesarean rate

    Caesarean rate in induced women

    Measured: Throughout the study period of 3 months

Secondary outcomes (5)
  1. 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

  2. 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

  3. 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

  4. Indication for induction of labour

    Proportions of main indications for labour induction

    Measured: Throughout the study period of 3 months

  5. 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.

  1. First posted5 Nov 2018
  2. Study start1 Sep 2018
  3. Primary completion31 Dec 2018
  4. Study completion28 Feb 2019

Resources

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)
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.

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.

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