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Can Differentiated Birth Care Improve the Service?

Differentiated Birth Service- an Improvement?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00857129
Enrollment
1111
Registered
2009-03-06
Start date
2006-09-30
Completion date
2013-12-31
Last updated
2014-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Risk Birth; Births With Low Risk Factor

Keywords

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

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.

Interventions

PROCEDURESpecial 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.

PROCEDURENormal Unit

low-risk patients randomised to Normal Unit

Sponsors

University of Tromso
CollaboratorOTHER
Ostfold Hospital Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Number of operative deliveriesone week

Secondary

MeasureTime frame
number of registered complicationsone week

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026