Ultrasound assessment of the fetal head position to prevent morbidity at instrumental delivery

ISRCTN	ISRCTN72230496
DOI	https://doi.org/10.1186/ISRCTN72230496
Protocol serial number	N/A
Sponsor	The Coombe Women and Infants University Hospital (Ireland)
Funder	Health Research Board (Ireland)

Submission date: 19/01/2011
Registration date: 23/02/2011
Last edited: 18/02/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Meenakshi Ramphul
Scientific

The Coombe Women and Infants University Hospital
The Coombe
Dublin
D8
Ireland

Study information

Primary study design	Interventional
Study design	Multicentre individually randomised parallel two-arm trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	IDUS - Instrumental Delivery and UltraSound
Study objectives	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(s)	Granted by the Research Ethics Committee of the Coombe Women & Infants University Hospital Dublin on the 5th October 2010
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Incorrect diagnosis of the fetal head position
Key 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.
Completion date	30/11/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	450
Key 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.
Key exclusion criteria	Women with a contraindication to instrumental delivery, or who have a limited understanding of English or are under 18 years of age.
Date of first enrolment	10/01/2011
Date of final enrolment	30/11/2013

Locations

Countries of recruitment

Ireland

Study participating centre

The Coombe Women and Infants University Hospital

Dublin
D8
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	nested observational study results	01/03/2015	18/02/2021	Yes	No
Protocol article	protocol	13/09/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/02/2021: Publication reference added.