Labour support and evidence based medicine: a randomised controlled trial of implementation

ISRCTN	ISRCTN33728802
DOI	https://doi.org/10.1186/ISRCTN33728802
Protocol serial number	M960512
Sponsor	Effective Care Research Unit (South Africa)
Funders	Department for International Development (UK), Medical Research Council (South Africa), International Childbirth Educators Association (USA), Johnson and Johnson (South Africa)

Submission date: 05/07/2006
Registration date: 14/07/2006
Last edited: 19/02/2008

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

Contact information

Prof Justus Hofmeyr
Scientific

Effective Care Research Unit
University of the Witwatersrand/University of Fort Hare/East London Hospital Complex
P Bag X9047
East London
5201
South Africa

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the Committee for Research on Human Subjects (Medical), University of the Witwatersrand on the 1st August 1998 (ref: M960512).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Whether women had a labour support person with them during labour.
Key secondary outcome measure(s)	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
Completion date	01/03/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	10
Key inclusion criteria	Maternity units within Gauteng Province, South Africa, that delivered a minimum of 150 women per month.
Key exclusion criteria	Maternity units within Gauteng Province, South Africa, that were directly linked to a university teaching scheme.
Date of first enrolment	01/10/1998
Date of final enrolment	01/03/2000

Locations

Countries of recruitment

South Africa

Study participating centre

Effective Care Research Unit

East London
5201
South Africa

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	30/04/2007		Yes	No