Condition category
Pregnancy and Childbirth
Date applied
13/08/2004
Date assigned
21/09/2004
Last edited
20/12/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nhmrc.gov.au/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes