Transperineal Ultrasound to Assess the Progress of Labour

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Placenta Praevia, Vaginismus

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acceptability and feasibilty<br>Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls | |
| Predictive Model<br>Nulliparous term labouring women with cephalic presentation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caesarean Delivery |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transperineal ultrasound, labour, sonopartogram, prediction model