Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
M960512
Study information
Scientific title
Acronym
Study hypothesis
Providing women with evidence based maternity care, with provision of labour support as a focus, will improve the care of women during childbirth.
Ethics approval
Ethics approval received from the Committee for Research on Human Subjects (Medical), University of the Witwatersrand on the 1st August 1998 (ref: M960512).
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Support during labour and evidence based medicine
Intervention
Two educational interventions for maternity staff: one focused on provision of labour support and the other on accessing evidence based maternity care information.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Whether women had a labour support person with them during labour.
Secondary outcome measures
Whether women during labour were:
1. Offered food or fluids
2. Left alone for long periods of time
3. Allowed to move during labour and delivery
4. Given an episiotomy
5. Given an enema
6. Shouted at
7. Struck or slapped
8. Unhappy with their care or percieved their care was bad
Overall trial start date
01/10/1998
Overall trial end date
01/03/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Maternity units within Gauteng Province, South Africa, that delivered a minimum of 150 women per month.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
10 maternity units
Participant exclusion criteria
Maternity units within Gauteng Province, South Africa, that were directly linked to a university teaching scheme.
Recruitment start date
01/10/1998
Recruitment end date
01/03/2000
Locations
Countries of recruitment
South Africa
Trial participating centre
Effective Care Research Unit
East London
5201
South Africa
Funders
Funder type
Research organisation
Funder name
Department for International Development (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Medical Research Council (South Africa)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
International Childbirth Educators Association (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Johnson and Johnson (South Africa)
Alternative name(s)
Johnson & Johnson, J&J
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/17470267
Publication citations
-
Results
Brown H, Hofmeyr GJ, Nikodem VC, Smith H, Garner P, Promoting childbirth companions in South Africa: a randomised pilot study., BMC Med, 2007, 5, 7, doi: 10.1186/1741-7015-5-7.