Can Differentiated Birth Care Improve the Service?

Not Applicable

Completed

• Conditions: Low Risk Birth; Births With Low Risk Factor
• Interventions: Procedure: Special birth unit; Procedure: Normal Unit

• Registration Number: NCT00857129
• Lead Sponsor: Ostfold Hospital Trust

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Primary Completion: 2010-03
• Study Completion: 2013-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1111

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3	Special birth unit	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.
2	Normal Unit	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.

Primary Outcome Measures

Name	Time	Method
Number of operative deliveries	one week

Secondary Outcome Measures

Name	Time	Method
number of registered complications	one week

Trial Locations

Locations (1)

Ostfold Hospital Trust; 🇳🇴 Fredrikstad, Norway