Can Differentiated Birth Care Improve the Service?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2013-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Low Risk Birth; Births With Low Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Normal Unit

Intervention Type PROCEDURE

low-risk patients randomised to Normal Unit

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.

Group Type EXPERIMENTAL

Special birth unit

Intervention Type 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.

Interventions

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Normal Unit

low-risk patients randomised to Normal Unit

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Normal Unit, low-risk women Standard care unit: The Special Unit.

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes