Transperineal ultrasound to assess the progress of labour
Research type
Research Study
Full title
The Sono-VE Study: Assessing the acceptability and feasibility of transperineal ultrasound and developing an ultrasound based predictive model for labour outcome.
IRAS ID
163370
Contact name
Christoph Lees
Contact email
Sponsor organisation
Joint Research Compliance Office, Imperial College London and Imperial College Healthcare NHS Trust
Duration of Study in the UK
2 years, 8 months, 2 days
Research summary
Purpose and Design:
We are investigating a novel, non-intrusive “transperineal ultrasound” technique to assess the neck of the womb and the baby. This allows objective, recordable measurements creating images that can be captured and stored electronically. The current digital vaginal examinations technique is intrusive, subjective, uncomfortable and associated with infection.
The Sono-VE study is a prospective observational study of transperineal ultrasound between 24-42 weeks gestation and a prospective longitudinal observational study in all term (37-42 weeks) labouring women.
This study aims to firstly assess the effectiveness and acceptability of transperineal ultrasound in women presenting between 24 and 42 weeks gestation in comparison with digital vaginal examination (VE). Secondly, in all term (37-42 weeks) labouring women, we aim to create an ultrasound based labour record, “a sonopartogram” and from this develop a predictive model for the outcome of labour.
Recruitment: Recruitment will take within Imperial College Healthcare NHS Trust.
Consent: Consent will be obtained by the project manager (part of the clinical care team) and/or a member of the research team.
Risk, Burden and Benefits: There are no known risks to mother or baby associated with ultrasound scan. Patients may experience slight discomfort when the probe is placed, though this is usually considered less than the discomfort experienced with vaginal examinations. The study does not offer any benefits/incentives but may be useful for other women in the future. Since this is an observational clinical study, any findings from the ultrasound measurements cannot be used in the delivery.
Confidentiality: Patient confidentiality will be maintained with the use of anonymised study number only.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/0227
Date of REC Opinion
12 Mar 2015
REC opinion
Further Information Favourable Opinion