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OpenTrials
Completed

NCT Number: NCT00857129

Can Differentiated Birth Care Improve the Service?

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

Completed

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Key information

Conditions

Low Risk Birth; Births With Low Risk Factor Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ostfold Hospital Trust

Fredrikstad, 1603, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Normal Unit

Procedure

low-risk patients randomised to Normal Unit

Other names: Normal Unit, low-risk women

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.

Other names: Standard care unit: The Special Unit.

Primary outcomes

  1. Number of operative deliveries

    Time frame: one week

Secondary outcomes

  1. number of registered complications

    Time frame: one week

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • University of Tromso

Registry information

Official study title

Differentiated Birth Service- an Improvement?

Important dates

Study start
2006
Primary completion
2010
Study completion
2013
First posted
Mar 6, 2009
Registry last updated
Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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