Transperineal Ultrasound to Assess the Progress of Labour

Vaginismus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430038
• Other study ID #: 14HH2428
• Status: Completed
• Start date: April 2015
• Est. completion date: January 19, 2018

Study information

• Verified date: February 2016
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: January 19, 2018
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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)

Related Conditions & MeSH terms

• Placenta Praevia
• Placenta Previa
• Vaginismus

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (5)

Lead Sponsor	Collaborator
Imperial College London	British Medical Association, Imperial College Healthcare NHS Trust, KU Leuven, Norwegian University of Science and Technology

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caesarean Delivery		24 months