Condition category
Mental and Behavioural Disorders
Date applied
04/11/2005
Date assigned
09/11/2005
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

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 women’s 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 measures

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

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

http://www7.health.gov.au/nhmrc/index.htm

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes