Transperineal Ultrasound to Assess the Progress of Labour

Completed

• Conditions: Vaginismus; Placenta Praevia

• Registration Number: NCT02430038
• Lead Sponsor: Imperial College London

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-04-29
• Primary Completion: 2018-01-19
• Study Completion: 2018-01-19
• Results First Submitted: 2023-05-16
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Results First Posted: 2024-10-07
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 584

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Caesarean Delivery	24 months	Number of Caesarean deliveries in the prediction group
Acceptability of Intrapartum Ultrasound	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.
Feasibility of Ultrasound Labour Parameters	24 months	The outcome was the number of women who had all labour parameters measured by ultrasound.

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom