Can Differentiated Birth Care Improve the Service?
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|ClinicalTrials.gov Identifier: NCT00857129|
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : October 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Low Risk Birth; Births With Low Risk Factor||Procedure: Normal Unit Procedure: Special birth unit||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1111 participants|
|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|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||December 2013|
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
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
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.
- Number of operative deliveries [ Time Frame: one week ]
- number of registered complications [ Time Frame: one week ]
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|
|Principal Investigator:||Pal Oian, PhD||University of Tromso, Norway|