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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00961987
Other study ID # 05-1309
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 18, 2009
Last updated August 18, 2009
Start date October 2009

Study information

Verified date August 2009
Source McMaster University
Contact Christine Rodriguez, MSc
Phone 905-525-9140
Email rodrigmc@mcmaster.ca
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

The aim of this pilot project is to determine if there are differences in patient outcomes and healthcare utilization between patients randomly assigned to usual care (a collaborative model of maternity care with co-located healthcare professionals but with referrals to off-site obstetricians) or to a collaborative model of maternity care with co-located healthcare professionals, including obstetricians. It is hypothesized that by creating a seamless interface between obstetrical consultation and ongoing longitudinal maternity care, patient outcomes (birth outcome data), patient satisfaction and healthcare utilization, including number of outpatient visits, ultrasounds, laboratory tests, consultations, etc, will be improved in the intervention group compared with the group receiving usual care. The results could potentially lead to other sites adopting this innovative model of maternity healthcare delivery.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 700
Est. completion date
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 60 Years
Eligibility Inclusion Criteria:

- 16 years of age or older

- Attending their intake appointment at the Centre

- Ability to understand English

- Legal status in Canada

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Collaborative model
Patients will be referred (if necessary) to an obstetrician who will be co-located in the Maternity Centre and who will be part of the collaborative model of maternity care.
Usual care
At present, if Maternity Centre patients require the specialized services of an obstetrician, the current standard of care is to refer them to obstetricians located offsite with no professional ties to the Maternity Centre

Locations

Country Name City State
Canada Maternity Centre Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient outcomes (birth outcomes) 9 months No
Secondary Patient satisfaction 9 months No
Secondary Healthcare utilization 9 months No
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