Condition category
Pregnancy and Childbirth
Date applied
19/10/2006
Date assigned
06/12/2006
Last edited
07/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.calgaryhealthregion.ca/dsrt/studycpcs.htm

Contact information

Type

Scientific

Primary contact

Dr Suzanne Tough

ORCID ID

Contact details

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

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

http://www.childrensinitiative.ca/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes