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
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 design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/10/1998 |
| Completion date | 01/03/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 10 maternity units |
| 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
5201
South Africa
Sponsor information
Effective Care Research Unit (South Africa)
Research organisation
Research organisation
University of the Witwatersrand/University of Fort Hare/East London Hospital Complex
P Bag X9047
East London
5201
South Africa
"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
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)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
