The Sono-VE Study: Assessing the Acceptability and Feasibility of Transperineal Ultrasound and Developing an Ultrasound Based Predictive Model for Labour Outcome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 584
- 试验地点
- 1
- 主要终点
- Caesarean Delivery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestation 24-42 completed weeks at study entry
- •Aged 18-44
- •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
排除标准
- •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)
结局指标
主要结局
Caesarean Delivery
时间窗: 24 months
Number of Caesarean deliveries in the prediction group
Acceptability of Intrapartum Ultrasound
时间窗: 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
时间窗: 24 months
The outcome was the number of women who had all labour parameters measured by ultrasound.
次要结局
未报告次要终点