Contact information
Type
Scientific
Primary contact
Dr Christine Roberts
ORCID ID
Contact details
Centre for Perinatal Health Services Research
QEII Building DO2
University of Sydney
NSW
2006
Australia
+61 (0)2 9351 7738
christine.roberts@perinatal.usyd.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
211051
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the effectiveness of a decision aid for women with a breech presentation compared with usual care.
Ethics approval
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)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2005
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women with a single breech-presenting baby at 34 weeks gestation or greater
2. Clinically eligible for external cephalic version (ECV)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
184
Participant 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
Recruitment start date
01/01/2005
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Australia
Trial participating centre
Centre for Perinatal Health Services Research
NSW
2006
Australia
Sponsor information
Organisation
Australian National Health and Medical Research Council (Australia)
Sponsor details
Office of NHMRC (MDP 100)
GPO Box 9848
Canberra
ACT
2601
Australia
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Australian National Health and Medical Research Council (Australia) (ref: 211051)
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
Protocol in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15606926
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17217360
Publication citations
-
Protocol
Roberts CL, Nassar N, Barratt A, Raynes-Greenow CH, Peat B, Henderson-Smart D, Protocol for the evaluation of a decision aid for women with a breech-presenting baby [ISRCTN14570598]., BMC Pregnancy Childbirth, 2004, 4, 1, 26, doi: 10.1186/1471-2393-4-26.
-
Results
Nassar N, Roberts CL, Raynes-Greenow CH, Barratt A, Peat B, , Evaluation of a decision aid for women with breech presentation at term: a randomised controlled trial [ISRCTN14570598]., BJOG, 2007, 114, 3, 325-333, doi: 10.1111/j.1471-0528.2006.01206.x.