Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
IDUS - Instrumental Delivery and UltraSound
Study hypothesis
The hypothesis is that an abdominal ultrasound scan performed in addition to routine clinical assessment reduces the incidence of incorrect diagnosis of the fetal head position which will reduce the risk of maternal and perinatal morbidity.
Ethics approval
Granted by the Research Ethics Committee of the Coombe Women & Infants University Hospital Dublin on the 5th October 2010
Study design
Multicentre individually randomised parallel two-arm trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Fetal head position in labour
Intervention
Eligible women who have consented to participate in the trial will be allocated to either the usual care arm or intervention arm. Women allocated to receive usual care will be managed according to RCOG guidelines and the local hospital protocol.
Women in the intervention group will be managed in the same way. In addition they will receive an ultrasound scan to assess the position of the fetal head and spine.
In both groups, the mother and the neonate will be followed-up until hospital discharge.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Incorrect diagnosis of the fetal head position
Secondary outcome measures
Secondary neonatal outcomes will include trauma, low Apgar scores, low arterial blood gases and admission to the neonatal intensive care unit (NICU). Neonatal trauma will include bruising, laceration, cephalhaematoma, retinal haemorrhage, facial nerve palsy, brachial plexus injury and fractures. Paired cord blood gases will be taken routinely to measure arterial and venous pH and base excess. Arterial pH below 7.10 and base excess greater than -12.0 mmol/l will be used as the threshold to define significant fetal acidosis.
Secondary maternal outcomes will include extensive perineal tearing involving the anal sphincter (third or fourth degree tears), postpartum haemorrhage, shoulder dystocia, and length of postnatal hospital stay. Primary post partum haemorrhage is defined as an estimated blood loss at delivery and in the first 24 hours of more than 500mls. Postnatal stay will be considered prolonged if more than 3 days' duration. Maternal and neonatal complications will be defined clinically according to the attending clinicians.
Overall trial start date
10/01/2011
Overall trial end date
30/11/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The study will be limited to nulliparous women at term with singleton cephalic pregnancies, aiming to deliver vaginally who require an instrumental delivery in the second stage of labour.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
450
Participant exclusion criteria
Women with a contraindication to instrumental delivery, or who have a limited understanding of English or are under 18 years of age.
Recruitment start date
10/01/2011
Recruitment end date
30/11/2013
Locations
Countries of recruitment
Ireland
Trial participating centre
The Coombe Women and Infants University Hospital
Dublin
D8
Ireland
Sponsor information
Organisation
The Coombe Women and Infants University Hospital (Ireland)
Sponsor details
The Coombe
Dublin
D8
Ireland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Health Research Board (Ireland)
Alternative name(s)
HRB
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Ireland
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
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22970933
Publication citations
-
Protocol
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 Childbirth, 2012, 12, 95, doi: 10.1186/1471-2393-12-95.