Condition category
Pregnancy and Childbirth
Date applied
05/07/2006
Date assigned
14/07/2006
Last edited
19/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Justus Hofmeyr

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Effective Care Research Unit (South Africa)

Sponsor details

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

Sponsor type

Research organisation

Website

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

private sector organisation

Funding Body Subtype

other non-profit

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, JNJ

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/17470267

Publication citations

  1. 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.

Additional files

Editorial Notes