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.
Citation:
Murphy DJ, Burke G, Montgomery AA, Ramphul M, 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., BMC pregnancy and childbirth, 12, 2012, 95Download Item:
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
Sponsor
Grant Number
Health Research Board (HRB)
Author's Homepage:
http://people.tcd.ie/murphyd4Description:
PUBLISHED
Author: MURPHY, DEIRDRE
Type of material:
Journal ArticleSeries/Report no:
BMC pregnancy and childbirth12
Availability:
Full text availableKeywords:
Randomised controlled trial, Intrapartum ultrasound, Second stage of labour, Fetal head positionDOI:
http://dx.doi.org/10.1186/1471-2393-12-95Metadata
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