A randomised controlled trial of educational counseling on the management of women who have suffered suboptimal outcomes during childbirth
| ISRCTN | ISRCTN14141270 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14141270 |
| Protocol serial number | 811019 |
| Sponsor | Hong Kong Health Services Research Fund (Hong Kong) |
| Funder | Hong Kong Health Services Research Fund (Hong Kong) |
- Submission date
- 09/10/2002
- Registration date
- 09/10/2002
- Last edited
- 02/07/2009
- 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
Dr DTS Lee
Scientific
Scientific
Department of Psychiatry
The Chinese University of Hong Kong
-
-
Hong Kong
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Unexpected outcomes of pregnancy is commonly associated with client dissatisfaction and psychological morbidity. Aims and objectives: To study whether proactive, systematic and interventionist educational counselling in addition to routine clinical care is effective in reducing psychological morbidity and in improving quality of life and client satisfaction among parturients who suffer from suboptimal outcomes during childbirth. |
| Ethics approval(s) | This information was not required at time of registration. |
| Health condition(s) or problem(s) studied | Obstetrics and gynaecology |
| Intervention | Educational counselling which consists of: 1. Education on the nature, etiology, management and prognosis of suboptimal outcomes 2. Counselling on the adverse emotions associated with suboptimal outcomes using techniques such as listening, clarification, debriefing, facilitation of affect expression and encouragement of positive coping mechanisms 3. Bereavement counselling, when the suboptimal outcomes involve fetal or neonatal death |
| Intervention type | Other |
| Primary outcome measure(s) |
A longitudinal assessment on the psychological well being using the Hospital Anxiety and |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 180 |
| Key inclusion criteria | Parturients who developed suboptimal outcomes during pregnancy. Suboptimal outcomes are defined as: 1. Perinatal deaths (intra-uterine death, stillbirth and neonatal death) 2. Treatment in the neonatal intensive care unit and special care unit 3. Unexpected obstetric events, which include significant antenatal complications, such as hypertension and ante-partum haemorrhage, and intra-uterine and post-partum events, such as emergency caesarean deliveries, operative vaginal deliveries and haemorrhage |
| Key exclusion criteria | Does not meet exclusion criteria |
| Date of first enrolment | 01/12/1998 |
| Date of final enrolment | 01/09/2000 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
Department of Psychiatry
-
-
Hong Kong
-
Hong Kong
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/09/2003 | Yes | No |
