Support Centre
23 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

New application
Updating record

governing board
data set
letter of agreement
request information
guidance notes

[ Print-friendly version ]
Ultrasound assessment of the fetal head position to prevent morbidity at instrumental delivery
DOI 10.1186/ISRCTN72230496
ClinicalTrials.gov identifier
EudraCT number
Public title Ultrasound assessment of the fetal head position to prevent morbidity at instrumental delivery
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
Serial number at source N/A
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.
Lay summary Not provided at time of registration
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
Countries of recruitment Ireland
Disease/condition/study domain Fetal head position in labour
Participants - 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.
Participants - exclusion criteria Women with a contraindication to instrumental delivery, or who have a limited understanding of English or are under 18 years of age.
Anticipated start date 10/01/2011
Anticipated end date 30/11/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 450
Interventions 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.
Primary outcome measure(s) Incorrect diagnosis of the fetal head position
Secondary outcome measure(s) 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.
Sources of funding Health Research Board (Ireland)
Trial website
Publications 1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22970933
Contact name Dr  Meenakshi  Ramphul
  Address The Coombe Women and Infants University Hospital
The Coombe
  City/town Dublin
  Zip/Postcode D8
  Country Ireland
Sponsor The Coombe Women and Infants University Hospital (Ireland)
  Address The Coombe
  City/town Dublin
  Zip/Postcode D8
  Country Ireland
  Sponsor website: http://www.tcd.ie/
Date applied 19/01/2011
Last edited 19/09/2012
Date ISRCTN assigned 23/02/2011
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.