Contact information
Type
Scientific
Primary contact
Dr Rhonda Small
ORCID ID
Contact details
Mother & Child Health Research
La Trobe University
251 Faraday Street
Carlton
3053
Australia
+61 (0)3 8341 8542
r.small@latrobe.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HS330
Study information
Scientific title
Acronym
Study hypothesis
The provision of a midwife-led debriefing session to women after an operative birth will reduce maternal depression at six months postpartum.
Ethics approval
Ethics approval received from La Trobe University Human Ethics Committee (ref: P1995/39).
Study design
Randomised controlled trial with off-site telephone randomisation determined by computer generated, adaptive biased coin randomisation schedules for each research midwife.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Maternal depression
Intervention
The intervention was a debriefing session for women with a research midwife during their postnatal stay. The key elements of the session involved:
1. Identifying emotional responses
2. Encouraging their expression and legitimising them
3. Provision of active listening
4. Reflection
5. Encouragement of the expression of womens experiences
6. Acceptance of distress, anger and pain
7. Naming and normalising the experience
8. Avoidance of offering solutions
Women in both arms of the trial received a pamphlet on sources of assistance for mothers on discharge from hospital after an operative birth.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Prevalence of maternal depression at six months postpartum measured by the Edinburgh Postnatal Depression Scale and overall maternal health status measured by the 36-item short form (SF-36) health status measure.
Secondary outcome measures
1. Satisfaction with care
2. Experience of the birth
3. Maternal health problems
4. For women participating in debriefing, their opinion about its helpfulness
Overall trial start date
01/03/1996
Overall trial end date
30/10/1998
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women giving birth by caesarean section, or with the assistance of forceps or vacuum extraction.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1040
Participant exclusion criteria
1. Women who had stillbirths or babies weighing less than 1500 g
2. Women who were ill or whose babies were ill
3. Women whose private obstetricians had refused permission to approach them
4. Women who had insufficient English to participate
Recruitment start date
01/03/1996
Recruitment end date
30/10/1998
Locations
Countries of recruitment
Australia
Trial participating centre
Mother & Child Health Research
Carlton
3053
Australia
Sponsor information
Organisation
National Health and Medical Resarch Council (NHMRC) (Australia)
Sponsor details
Office of NHMRC (MDP 100)
GPO Box 9848
Canberra
ACT
2601
Australia
+61 (0)2 6289 1555
research@nhmrc.gov.au
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
National Health and Medical Resarch Council (NHMRC) (Australia) - Health and Human Services Research and Development Grants (ref: HS330)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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:
1. http://www.ncbi.nlm.nih.gov/pubmed/11053173
2. http://www.ncbi.nlm.nih.gov/pubmed/16509986 (four to six year follow-up)
Publication citations
-
Small R, Lumley J, Donohue L, Potter A, Waldenström U, Randomised controlled trial of midwife led debriefing to reduce maternal depression after operative childbirth., BMJ, 2000, 321, 7268, 1043-1047.
-
Small R, Lumley J, Toomey L, Midwife-led debriefing after operative birth: four to six year follow-up of a randomised trial [ISRCTN24648614]., BMC Med, 2006, 4, 3, doi: 10.1186/1741-7015-4-3.