Transperineal Ultrasound to Assess the Progress of Labour

NCT02430038 | Completed Results

• 1 other identifier: 14HH2428
• Study Type: observational
• Target: 584
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Praevia; Vaginismus

Keywords

transperineal ultrasound; labour; sonopartogram; prediction model

Outcome Measures

Primary Outcomes (3)

• Caesarean Delivery

  Number of Caesarean deliveries in the prediction group

  24 months

• Acceptability of Intrapartum Ultrasound

  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.

  24 months

• Feasibility of Ultrasound Labour Parameters

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

  24 months

Study Arms (3)

Acceptability

To assess acceptability of intervention. Some patients from this group also participated in the other groups.

Feasibility

Is it possible for ultrasound to measure labour parameters, where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls. Some patients from this group also participated in the other groups.

Predictive Model

Nulliparous term labouring women with cephalic presentation. Some patients from this group also participated in the other groups.

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Group 1: acceptability and feasibility group Group 2: predictive model group

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Placenta Previa; Vaginismus

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Results Point of Contact

• Title: Professor Christoph Lees
• Organization: Imperial College

christoph.lees@nhs.net

02083831000

Study Officials

• Christoph Lees, MD MRCOG

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: April 29, 2015
• Study Start: April 1, 2015
• Primary Completion: January 19, 2018
• Study Completion: January 19, 2018
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)