Can Differentiated Birth Care Improve the Service?
This study is ongoing, but not recruiting participants.
Sponsor:
Ostfold Hospital Trust
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 5, 2009 | ||||
| Last Updated Date | August 22, 2012 | ||||
| Start Date ICMJE | September 2006 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of operative deliveries [ Time Frame: one week ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Number of ceacarian sectios [ Time Frame: one week ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00857129 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
number of registered complications [ Time Frame: one week ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Can Differentiated Birth Care Improve the Service? | ||||
| Official Title ICMJE | Differentiated Birth Service- an Improvement? | ||||
| Brief Summary | Prospective evaluation of birth complication in three differently staffed and equipped units in the same hospital. |
||||
| 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 Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
||||
| Condition ICMJE | Low Risk Birth; Births With Low Risk Factor | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 1111 | ||||
| Estimated Completion Date | December 2013 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00857129 | ||||
| Other Study ID Numbers ICMJE | 3100 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Stine Bernitz, Ostfold Hospital Trust | ||||
| Study Sponsor ICMJE | Ostfold Hospital Trust | ||||
| Collaborators ICMJE | University of Tromso | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Ostfold Hospital Trust | ||||
| Verification Date | August 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||