Condition category
Pregnancy and Childbirth
Date applied
19/01/2011
Date assigned
23/02/2011
Last edited
19/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Meenakshi Ramphul

ORCID ID

Contact details

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

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 measures

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

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

http://www.tcd.ie/

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

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

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22970933

Publication citations

  1. 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.

Additional files

Editorial Notes