Can Differentiated Birth Care Improve the Service?

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
Stine Bernitz, Ostfold Hospital Trust
ClinicalTrials.gov Identifier:
NCT00857129
First received: March 5, 2009
Last updated: August 22, 2012
Last verified: August 2012

March 5, 2009
August 22, 2012
September 2006
March 2010   (final data collection date for primary outcome measure)
Number of operative deliveries [ Time Frame: one week ] [ Designated as safety issue: Yes ]
Number of ceacarian sectios [ Time Frame: one week ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00857129 on ClinicalTrials.gov Archive Site
number of registered complications [ Time Frame: one week ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Can Differentiated Birth Care Improve the Service?
Differentiated Birth Service- an Improvement?

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Low Risk Birth; Births With Low Risk Factor
  • Procedure: Normal Unit
    low-risk patients randomised to Normal Unit
    Other Name: Normal Unit, 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.
  • 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.
    Intervention: 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.
    Intervention: Procedure: Special birth unit
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1111
December 2013
March 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00857129
3100
No
Stine Bernitz, Ostfold Hospital Trust
Ostfold Hospital Trust
University of Tromso
Principal Investigator: Pal Oian, PhD University of Tromso, Norway
Ostfold Hospital Trust
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP