Transperineal Ultrasound to Assess the Progress of Labour

Imperial College London

Status: Completed

Conditions: Placenta Praevia; Vaginismus

Study type: Observational

Funder types: Other

Identifiers

NCT02430038

14HH2428

Details and patient eligibility

About

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.

Full 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.

Enrollment: 584 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

584 participants in 3 patient groups

Acceptability

Description:

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

Feasibility

Description:

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

Description:

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