Transperineal Ultrasound to Assess the Progress of Labour

March 20, 2019 updated by: Imperial College London

The Sono-VE Study: Assessing the Acceptability and Feasibility of Transperineal Ultrasound and Developing an Ultrasound Based Predictive Model for Labour Outcome.

This 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.

Study Overview

Status

Completed

Conditions

Detailed Description

This 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.

AIMS:

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, investigators aim to create an ultrasound based labour record, "a sonopartogram" and from this develop a predictive model for the outcome of labour.

Study Type

Observational

Enrollment (Actual)

297

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Group 1: acceptability and feasibility group

Group 2: predictive model group

Description

Inclusion Criteria:

  • Gestation 24-42 completed weeks at study entry
  • Aged 18-44
  • Cephalic
  • Singleton pregnancies
  • Nulliparous
  • Multiparous (excluded for the term predictive model group)
  • Multiple pregnancies (excluded for the term predictive model group)
  • Established (Active) phase of labour (included for the term predictive model group) o Clinician opinion that patient is in the established phase of labour according to the current NICE guidelines

Exclusion Criteria:

  • Younger than 18 years.
  • Imminent iatrogenic intention to deliver
  • Life threatening maternal or fetal compromise needing immediate medical attention and/or delivery
  • Women who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study.
  • Miscarriage
  • Intra-uterine death
  • Previous cervical surgery eg. cone biopsy, cervical cerclage. Note- Single LLETZ is not excluded.
  • Non-cephalic presentations
  • Multiple pregnancies (for the term predictive model group)
  • Multiparous patients (for the term predictive model group)
  • Not in established labour (for the term predictive model group)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acceptability and feasibilty
Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls
Predictive Model
Nulliparous term labouring women with cephalic presentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Caesarean Delivery
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Norwegian University of Science and Technology
KU Leuven
Imperial College Healthcare NHS Trust
British Medical Association

Investigators

  • Principal Investigator: Christoph Lees, MD MRCOG, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

January 19, 2018

Study Completion (Actual)

January 19, 2018

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14HH2428

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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