Clinical trial NCT02430038: Transperineal Ultrasound to Assess the Progress of Labour
Official title: The Sono-VE Study: Assessing the Acceptability and Feasibility of Transperineal Ultrasound and Developing an Ultrasound Based Predictive Model for Labour Outcome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Praevia
Vaginismus
Keywords: transperineal ultrasound
labour
sonopartogram
prediction model
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
name: KU Leuven
name: Norwegian University of Science and Technology
name: British Medical Association
First posted: 2015-04-29
Enrollment: 584
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: acceptability and feasibility group

Group 2: predictive model group

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Caesarean Delivery
timeFrame: 24 months
measure: Acceptability of Intrapartum Ultrasound
timeFrame: 24 months
measure: Feasibility of Ultrasound Labour Parameters
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Christoph Lees, MD MRCOG
role: PRINCIPAL_INVESTIGATOR
References: