ISRCTN ISRCTN64070727
DOI https://doi.org/10.1186/ISRCTN64070727
Secondary identifying numbers 10
Submission date
19/10/2006
Registration date
06/12/2006
Last edited
07/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Suzanne Tough
Scientific

Alberta Children's Hospital
2888 Shaganappi Trail NW
Calgary
T3B 6A8
Canada

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Scientific title
Study acronymCPC Study
Study objectivesIt 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(s)Conjoint Health Ethics Research Board, Calgary Health Region and University of Calgary. Approval date: June 7, 2001(ref: #15763).
Health condition(s) or problem(s) studiedPregnancy
InterventionPregnant 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 typeOther
Primary outcome measure1. Resource utilisation
2. Provision of information
Secondary outcome measures1. Mental health
2. Lifestyle choices
3. Satisfaction with care
Overall study start date01/04/2001
Completion date01/06/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants1,800
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/04/2001
Date of final enrolment01/06/2004

Locations

Countries of recruitment

  • Canada

Study participating centre

Alberta Children's Hospital
Calgary
T3B 6A8
Canada

Sponsor information

Calgary Children's Initiative (Canada)
Research organisation

Suite 600
1202 Centre Street S.E.
Calgary
T2G 5A5
Canada

Website http://www.childrensinitiative.ca/

Funders

Funder type

Research organisation

Calgary Children's Initiative (Canada)

No information available

Physician Partnership Steering Committee (Canada)

No information available

Added as of 07/02/2008:

No information available

Alberta Heritage Foundation for Medical Research (Canada)
Government organisation / Local government
Alternative name(s)
AHFMR
Location
Canada
Child and Women's Health Portfolio, Calgary Health Region (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results: 01/09/2006 Yes No
Results article Results: 01/12/2006 Yes No
Results article Results: 06/07/2007 Yes No