Evaluation of a decision aid for women with a breech-presenting baby

ISRCTN	ISRCTN14570598
DOI	https://doi.org/10.1186/ISRCTN14570598
Protocol serial number	211051
Sponsor	Australian National Health and Medical Research Council (Australia)
Funder	Australian National Health and Medical Research Council (Australia) (ref: 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

Centre for Perinatal Health Services Research
QEII Building DO2
University of Sydney
NSW
2006
Australia

Phone	+61 (0)2 9351 7738
Email	christine.roberts@perinatal.usyd.edu.au

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	1. Knowledge 2. Decisional conflict 3. Anxiety 4. Satisfaction with decision-making
Key secondary outcome measure(s)	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
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

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	01/03/2007		Yes	No
Protocol article	protocol	20/12/2004		Yes	No

Editorial Notes

18/12/2017: internal review.