Can Differentiated Birth Care Improve the Service?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Ostfold Hospital Trust.
Recruitment status was  Active, not recruiting
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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Differentiated Birth Service- an Improvement?

Further study details as provided by Ostfold Hospital Trust:

Primary Outcome Measures:
  • Number of operative deliveries [ Time Frame: one week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • number of registered complications [ Time Frame: one week ] [ Designated as safety issue: Yes ]

Enrollment: 1111
Study Start Date: September 2006
Estimated Study Completion Date: December 2013
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857129

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

No publications provided

Responsible Party: Stine Bernitz, Midwife MSc PhD student, Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT00857129     History of Changes
Other Study ID Numbers: 3100
Study First Received: March 5, 2009
Last Updated: August 22, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by 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

ClinicalTrials.gov processed this record on September 16, 2014