Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10
Study information
Scientific title
Acronym
CPC Study
Study hypothesis
It was hypothesised that additional community-based prenatal support from nurses and home visitors would improve the use of prenatal resources among women at low medical risk, including those experiencing challenges such as poverty, language barriers, abuse, and low self esteem.
Ethics approval
Conjoint Health Ethics Research Board, Calgary Health Region and University of Calgary. Approval date: June 7, 2001(ref: #15763).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Pregnancy
Intervention
Pregnant women randomised to:
1. Standard of prenatal care,
2. Standard of prenatal care plus supplementary nurse, or
3. Standard of care plus supplementary nurse and home visitor.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Resource utilisation
2. Provision of information
Secondary outcome measures
1. Mental health
2. Lifestyle choices
3. Satisfaction with care
Overall trial start date
01/04/2001
Overall trial end date
01/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. More than or equal to 18 years
2. Speak English, French, Punjabi, Urdu, Arabic, Cantonese, Mandarin
3. Live in city limits
4. Not attended first prenatal class prior to intake interview
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1,800
Participant exclusion criteria
1. Less than 18 years
2. Could not speak English, French, Punjabi, Urdu, Arabic, Cantonese, or Mandarin
3. Live outside city limits
4. Attended first prenatal class prior to intake interview
Recruitment start date
01/04/2001
Recruitment end date
01/06/2004
Locations
Countries of recruitment
Canada
Trial participating centre
Alberta Children's Hospital
Calgary
T3B 6A8
Canada
Sponsor information
Organisation
Calgary Children's Initiative (Canada)
Sponsor details
Suite 600
1202 Centre Street S.E.
Calgary
T2G 5A5
Canada
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Calgary Children's Initiative (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Physician Partnership Steering Committee (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Added as of 07/02/2008:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Alberta Heritage Foundation for Medical Research (Canada)
Alternative name(s)
AHFMR
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Canada
Funder name
Child and Women's Health Portfolio, Calgary Health Region (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17118044
Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16948718
Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17617914
Publication citations
-
Results
Au F, Shiell A, van der Pol M, Johnston DW, Tough S, Does supplementary prenatal nursing and home visitation reduce healthcare costs in the year after childbirth?, J Adv Nurs, 2006, 56, 6, 657-668, doi: 10.1111/j.1365-2648.2006.04036.x.
-
Results
Tough SC, Johnston DW, Siever JE, Jorgenson G, Slocombe L, Lane C, Clarke M, Does supplementary prenatal nursing and home visitation support improve resource use in a universal health care system? A randomized controlled trial in Canada., Birth, 2006, 33, 3, 183-194, doi: 10.1111/j.1523-536X.2006.00103.x.
-
Results
Tough SC, Siever JE, Johnston DW, Retaining women in a prenatal care randomized controlled trial in Canada: implications for program planning., BMC Public Health, 2007, 7, 148, doi: 10.1186/1471-2458-7-148.