Can Differentiated Birth Care Improve the Service?

Low Risk Birth; Births With Low Risk Factor Clinical Trial

Official title:

Differentiated Birth Service- an Improvement?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857129
• Other study ID #: 3100
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: October 17, 2014
• Start date: September 2006
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1111
• Est. completion date: December 2013
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Low Risk Birth; Births With Low Risk Factor

Intervention

Procedure:
• Normal Unit
low-risk patients randomised to Normal Unit
• 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.

Locations

Country	Name	City	State
Norway	Ostfold Hospital Trust	Fredrikstad

Sponsors (2)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of operative deliveries		one week	Yes
Secondary	number of registered complications		one week	Yes