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

ISRCTN ISRCTN33728802
DOI https://doi.org/10.1186/ISRCTN33728802
Secondary identifying numbers M960512
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

Study designCluster randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesProviding 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) studiedSupport during labour and evidence based medicine
InterventionTwo educational interventions for maternity staff: one focused on provision of labour support and the other on accessing evidence based maternity care information.
Intervention typeOther
Primary outcome measureWhether women had a labour support person with them during labour.
Secondary outcome measuresWhether 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 study start date01/10/1998
Completion date01/03/2000

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants10 maternity units
Key inclusion criteriaMaternity units within Gauteng Province, South Africa, that delivered a minimum of 150 women per month.
Key exclusion criteriaMaternity units within Gauteng Province, South Africa, that were directly linked to a university teaching scheme.
Date of first enrolment01/10/1998
Date of final enrolment01/03/2000

Locations

Countries of recruitment

  • South Africa

Study participating centre

Effective Care Research Unit
East London
5201
South Africa

Sponsor information

Effective Care Research Unit (South Africa)
Research organisation

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

ROR logo "ROR" https://ror.org/03rp50x72

Funders

Funder type

Research organisation

Department for International Development (UK)

No information available

Medical Research Council (South Africa)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom
International Childbirth Educators Association (USA)

No information available

Johnson and Johnson (South Africa)
Government organisation / For-profit companies (industry)
Alternative name(s)
Johnson & Johnson, johnson & Johnson Services, Inc., Johnson&Johnson, 强生公司, Johnson & Johnson Private Limited, ジョンソン・エンド・ジョンソント, J&J, JNJ
Location
United States of America

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 30/04/2007 Yes No