Evaluation of a decision aid for women with a breech-presenting baby
| ISRCTN | ISRCTN14570598 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14570598 |
| Secondary identifying numbers | 211051 |
- Submission date
- 13/08/2004
- Registration date
- 21/09/2004
- Last edited
- 18/12/2017
- 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 Christine Roberts
Scientific
Scientific
Centre for Perinatal Health Services Research
QEII Building DO2
University of Sydney
NSW
2006
Australia
| Phone | +61 (0)2 9351 7738 |
|---|---|
| christine.roberts@perinatal.usyd.edu.au |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Evaluation of a decision aid for women with a breech-presenting baby |
| Study objectives | To evaluate the effectiveness of a decision aid for women with a breech presentation compared with usual care. |
| Ethics approval(s) | Ethics approval received from: 1. The Central Sydney Area Health Service Ethics Review Committee (ref: X01-0067) 2. The University of Sydney Human Ethics Committee (ref: 3806) |
| Health condition(s) or problem(s) studied | Breech pregnancy at term |
| Intervention | The study group will receive the ECV Decision Aid which was developed using the Ottawa Decision Support Framework, including a systematic review of the evidence about the benefits and risks of the options for breech pregnancy (attempt ECV or choose planned caesarean section). It comprises an audiotape with a supplementary booklet and worksheet, a format that can be taken home and discussed with a partner. The control group will receive standard information on management options for breech pregnancy from their usual pregnancy care provider. At the next antenatal visit, all women will complete a follow-up questionnaire and those in the study group will review their decision aid worksheet with the research nurse. |
| Intervention type | Other |
| Primary outcome measure | 1. Knowledge 2. Decisional conflict 3. Anxiety 4. Satisfaction with decision-making |
| Secondary outcome measures | 1. Numbers of ECVs undergone 2. ECV success rate 3. Rates of pregnancy complications 4. Perinatal outcomes: 4.1. Mode of delivery (vaginal, emergency or planned CS) 4.2. Enrolment to delivery interval 4.3. Gestational age 4.4. Birthweight 4.5. Apgar scores 4.6. Perinatal deaths 4.7. Neonatal Intensive Care Unit admission 4.8. Maternal haemorrhage (antepartum or postpartum) 4.9. Length of stay |
| Overall study start date | 01/01/2005 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 184 |
| Key inclusion criteria | 1. Women with a single breech-presenting baby at 34 weeks gestation or greater 2. Clinically eligible for external cephalic version (ECV) |
| Key exclusion criteria | 1. Women presenting with a breech in labour 2. Multiple pregnancies 3. Previous Caesarean Section (CS) 4. Severe foetal anomaly 5. Ruptured membranes 6. Indications for CS anyway |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Australia
Study participating centre
Centre for Perinatal Health Services Research
NSW
2006
Australia
2006
Australia
Sponsor information
Australian National Health and Medical Research Council (Australia)
Research council
Research council
Office of NHMRC (MDP 100)
GPO Box 9848
Canberra, ACT
2601
Australia
| Website | http://www.nhmrc.gov.au/ |
|---|---|
"ROR" |
https://ror.org/011kf5r70 |
Funders
Funder type
Research council
Australian National Health and Medical Research Council (Australia) (ref: 211051)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/12/2004 | Yes | No | |
| Results article | results | 01/03/2007 | Yes | No |
Editorial Notes
18/12/2017: internal review.
