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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2012

Open Access 01-12-2012 | Study protocol

Study Protocol. IDUS – Instrumental delivery & ultrasound. A multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery

Authors: Deirdre J Murphy, Gerard Burke, Alan A Montgomery, Meenakshi Ramphul, The IDUS StudyGroup

Published in: BMC Pregnancy and Childbirth | Issue 1/2012

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Abstract

Background

Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 – 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice.

Methods/Design

A multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha.

Discussion

It is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries.

Trial registration

Current Controlled Trials ISRCTN72230496
Appendix
Available only for authorised users
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Metadata
Title
Study Protocol. IDUS – Instrumental delivery & ultrasound. A multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery
Authors
Deirdre J Murphy
Gerard Burke
Alan A Montgomery
Meenakshi Ramphul
The IDUS StudyGroup
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2012
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/1471-2393-12-95

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