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Can Differentiated Birth Care Improve the Service?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00857129
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : October 20, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
Prospective evaluation of birth complication in three differently staffed and equipped units in the same hospital.

Condition or disease Intervention/treatment
Low Risk Birth; Births With Low Risk Factor Procedure: Normal Unit Procedure: Special birth unit

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1111 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Differentiated Birth Service- an Improvement?
Study Start Date : September 2006
Primary Completion Date : March 2010
Study Completion Date : December 2013
Arms and Interventions

Arm Intervention/treatment
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
low-risk patients randomised to Normal Unit
Other Name: Normal Unit, low-risk women
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
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.
Other Name: Standard care unit: The Special Unit.

Outcome Measures

Primary Outcome Measures :
  1. Number of operative deliveries [ Time Frame: one week ]

Secondary Outcome Measures :
  1. number of registered complications [ Time Frame: one week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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.
Contacts and Locations

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): NCT00857129

Ostfold Hospital Trust
Fredrikstad, Norway, 1603
Sponsors and Collaborators
Ostfold Hospital Trust
University of Tromso
Principal Investigator: Pal Oian, PhD University of Tromso, Norway
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stine Bernitz, Midwife MSc PhD student, Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT00857129     History of Changes
Other Study ID Numbers: 3100
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: October 20, 2014
Last Verified: October 2014

Keywords provided by Stine Bernitz, Ostfold Hospital Trust:
"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