CClinicalTrials.gg
CompletedNCT00857129Updated Oct 20, 2014

Can Differentiated Birth Care Improve the Service?

An interventional study of Normal Unit and Special birth unit in Low Risk Birth; Births With Low Risk Factor, sponsored by Ostfold Hospital Trust. Completed at 1 site in Norway. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-20.

Sponsored by Ostfold Hospital Trust · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,111
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Prospective evaluation of birth complication in three differently staffed and equipped units in the same hospital.

Read the detailed description

The study will include approximately 1000 normal births in a county hospital. The mothers are randomly assigned to one of three different maternal wards; one run by midwives, one normally equipped according to national standards for a county hospital and one prepared for complicated births. Endpoints are number of operative births and complications.

02

Conditions studied

  • Low Risk Birth; Births With Low Risk Factor

Keywords

  • "normal birth"
  • "birth outcome"
  • "low risk birth"
  • "low risk units"
  • If type of birth care unit have effect on birth outcome
  • Apgar score
  • breast feeding frequency
  • patient satisfaction
03

In context

Lead sponsor

Ostfold Hospital Trust is the lead sponsor of 48 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy mother, normal pregnancy, no prior operations on the uterus, no prior birth complications, no condition with negative effect on pregnancy or birth,one fetus in head position, spontaneously going into birth between week 36,1 and 41,6 of pregnancy,normal cardiotocograph test BMI of 32 or less, smoking no more than 10 cigarettes per day, wants to participate in the study and signs the consent form.

Exclusion criteria

Exclusion Criteria:

  • Any condition that has negative effect on the pregnancy or the birth, more than one fetus, all other positions than head position, induction of labor,pre term or post term birth, BMI of more than 32, smoking more than 10 cigarettes per day, does not want to participate.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,111 participants (actual)

Study arms

  • No intervention
    1

    Low risk women with expected normal birth are being Randomized to The Midwife-led Unit, with low amount of intervention, No epidural is offered, no medical augmentation available, unless for the active phase of the second stage. If extended surveillance is necessary or if the birth no longer is considered to be normal and needs to be taken over by a doctor, the woman will be transferred to either the Normal Unit or the Special Unit

  • Experimental
    2

    Low-risk women are randomised to this Low-risk maternal unit, The Normal Unit.The unit is organised for low-risk women with expected normal birth. The unit has access to extended surveillance, epidural and operative vaginal deliveries. If extended surveillance is necessary for a woman randomised to this unit, she does not have to be transferred to a higher level of care. Instrumental vaginal deliveries can be carried out at this unit.

    Procedure: Normal Unit

  • Experimental
    3

    Women with expected normal births are being randomised to this Special birth unit designed to take care of women before, under and after birth. The Special Unit cares for women with extended need for surveillance, but does also handle low-risk women.

    Procedure: Special birth unit

Interventions

  • ProcedureNormal Unit

    low-risk patients randomised to Normal Unit

    Also known as: Normal Unit, low-risk women

  • ProcedureSpecial birth unit

    Low-risk women are randomised to the Special birth unit. Organised to take care of women with extended need for surveillance before, under and after birth.

    Also known as: Standard care unit: The Special Unit.

06

What researchers measure

Primary outcomes

  1. Number of operative deliveries

    Time frame: one week

Secondary outcomes

  1. number of registered complications

    Time frame: one week

07

Study locations

1 site
  • Ostfold Hospital Trust
    Fredrikstad, 1603, Norway
08

References and documents

Publications

  • Bernitz S, Oian P, Sandvik L, Blix E. Evaluation of satisfaction with care in a midwifery unit and an obstetric unit: a randomized controlled trial of low-risk women. BMC Pregnancy Childbirth. 2016 Jun 18;16(1):143. doi: 10.1186/s12884-016-0932-x. PubMed 27316335 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00857129
Lead sponsor
Ostfold Hospital Trust
Collaborators
University of Tromso
Responsible party
Stine Bernitz (Midwife MSc PhD student, Ostfold Hospital Trust) — Principal investigator
First posted
Mar 6, 2009
Start date
Sep 2006
Primary completion
Mar 2010
Completion
Dec 2013
Last update
Oct 20, 2014

Study contacts

Pal Oian, PhD
principal investigator · University of Tromso, Norway

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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