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| Name | Class |
|---|---|
| University of Tromso | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | 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 | |
| 2 | Experimental | 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. |
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| 3 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Unit | Procedure | low-risk patients randomised to Normal Unit |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of operative deliveries | one week |
| Measure | Description | Time Frame |
|---|---|---|
| number of registered complications | one week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pal Oian, PhD | University of Tromso, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ostfold Hospital Trust | Fredrikstad | 1603 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27316335 | Derived | Bernitz S, Oian P, Sandvik L, Blix E. Evaluation of satisfaction with care in a midwifery unit and an obstetric unit: a randomized controlled trial of low-risk women. BMC Pregnancy Childbirth. 2016 Jun 18;16(1):143. doi: 10.1186/s12884-016-0932-x. |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Special birth unit | Procedure | 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. |
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