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NCT Number: NCT02430038

Transperineal Ultrasound to Assess the Progress of Labour

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Caesarean Delivery

    Time frame: 24 months

    Number of Caesarean deliveries in the prediction group

  2. Acceptability of Intrapartum Ultrasound

    Time frame: 24 months

    Acceptability of transabdominal and transperineal ultrasound to pregnant and labouring women. Use of modified W-DEQ questionnaires pre and post assessment. We recorded the number of women who completed both questionnaires.

  3. Feasibility of Ultrasound Labour Parameters

    Time frame: 24 months

    The outcome was the number of women who had all labour parameters measured by ultrasound.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2015
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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