Can Differentiated Birth Care Improve the Service?

Differentiated Birth Service- an Improvement?

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

Study Overview

• Status: Completed
• Conditions: Low Risk Birth; Births With Low Risk Factor
• Intervention / Treatment: Procedure: Normal Unit; Procedure: Special birth unit

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 Type: Interventional
• Enrollment (Actual): 1111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Fredrikstad, Norway, 1603
    • Ostfold Hospital Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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
Experimental: 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.	Procedure: Normal Unit; low-risk patients randomised to Normal Unit; Other Names: Normal Unit, low-risk women
Experimental: 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.	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.; Other Names: Standard care unit: The Special Unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of operative deliveries	one week

Secondary Outcome Measures

Outcome Measure	Time Frame
number of registered complications	one week

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Collaborators: University of Tromso
• Investigators: Principal Investigator: Pal Oian, PhD, University of Tromso, Norway

Publications and helpful links

General Publications

• Bernitz S, Oian P, Sandvik L, Blix E. Evaluation of satisfaction with care in a midwifery unit and an obstetric unit: a randomized controlled trial of low-risk women. BMC Pregnancy Childbirth. 2016 Jun 18;16(1):143. doi: 10.1186/s12884-016-0932-x.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 5, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (Estimate): March 6, 2009

Study Record Updates

• Last Update Posted (Estimate): October 20, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: patient satisfaction; Apgar score; "normal birth"; "birth outcome"; "low risk birth"; "low risk units"; If type of birth care unit have effect on birth outcome; breast feeding frequency
• Other Study ID Numbers: 3100