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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2004

Open Access 01-12-2004 | Study protocol

Protocol for the evaluation of a decision aid for women with a breech-presenting baby [ISRCTN14570598]

Authors: Christine L Roberts, Natasha Nassar, Alexandra Barratt, Camille H Raynes-Greenow, Brian Peat, David Henderson-Smart

Published in: BMC Pregnancy and Childbirth | Issue 1/2004

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Abstract

Background

There is now good evidence about the management options for pregnant women with a breech presentation (buttocks or feet rather than head-first) at term; external cephalic version (ECV) – the turning of a breech baby to a head-down position and/or planned caesarean section (CS). Each of these options has benefits and risks and the relative importance of these vary for each woman, subject to her personal values and preferences, a situation where a decision aid may be helpful.
Decision aids are designed to assist patients and their doctors in making informed decisions using information that is unbiased and based on high quality research evidence. Decision aids are non-directive in the sense that they do not aim to steer the user towards any one option, but rather to support decision making which is informed and consistent with personal values.
The ECV decision aid 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. It comprises an audiotape with a supplementary booklet and worksheet, a format that can be taken home and discussed with a partner. This project aims to evaluate the ECV decision aid for women with a breech presenting baby in late pregnancy.

Study design

We aim to evaluate the effectiveness of the decision aid compared with usual care in a randomised controlled trial in maternity hospitals that offer ECV. The study group will receive the decision aid in addition to usual care and the control group will receive standard information on management options for breech presentation from their usual pregnancy care provider. Approximately 184 women with a single breech-presenting baby at greater than 34 weeks gestation and who are clinically eligible for ECV will be recruited for the trial.
The primary outcomes of the study are knowledge, decisional conflict, anxiety and satisfaction with decision-making that will be assessed using self-administered questionnaires. The decision aid is not intended to influence either the uptake of either ECV or planned CS, however we will monitor health service utilisation rates and maternal and perinatal outcomes.
Appendix
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Metadata
Title
Protocol for the evaluation of a decision aid for women with a breech-presenting baby [ISRCTN14570598]
Authors
Christine L Roberts
Natasha Nassar
Alexandra Barratt
Camille H Raynes-Greenow
Brian Peat
David Henderson-Smart
Publication date
01-12-2004
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2004
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/1471-2393-4-26

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