Midwife-led debriefing after operative birth
| ISRCTN | ISRCTN24648614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24648614 |
| Secondary identifying numbers | HS330 |
- Submission date
- 04/11/2005
- Registration date
- 09/11/2005
- Last edited
- 02/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rhonda Small
Scientific
Scientific
Mother & Child Health Research
La Trobe University
251 Faraday Street
Carlton
3053
Australia
| Phone | +61 (0)3 8341 8542 |
|---|---|
| r.small@latrobe.edu.au |
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | Midwife-led debriefing after operative birth |
| Study objectives | The provision of a midwife-led debriefing session to women after an operative birth will reduce maternal depression at six months postpartum. |
| Ethics approval(s) | Ethics approval received from La Trobe University Human Ethics Committee (ref: P1995/39). |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/1996 |
| Completion date | 30/10/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1040 |
| Key inclusion criteria | Women giving birth by caesarean section, or with the assistance of forceps or vacuum extraction. |
| Key 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 |
| Date of first enrolment | 01/03/1996 |
| Date of final enrolment | 30/10/1998 |
Locations
Countries of recruitment
- Australia
Study participating centre
Mother & Child Health Research
Carlton
3053
Australia
3053
Australia
Sponsor information
National Health and Medical Research Council
Research council
Research council
Office of NHMRC (MDP 100)
GPO Box 9848
Canberra, ACT
2601
Australia
| Phone | +61 (0)2 6289 1555 |
|---|---|
| research@nhmrc.gov.au | |
| Website | http://www7.health.gov.au/nhmrc/index.htm |
"ROR" |
https://ror.org/011kf5r70 |
Funders
Funder type
Research council
National Health and Medical Research Council
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/10/2000 | Yes | No | ||
| Results article | 01/03/2006 | Yes | No |
Editorial Notes
02/11/2022: Internal review.
15/01/2020: Internal review.
