Ultrasound Prediction of Delivery Mode: Can the First Stage Prediction Model be Further Improved?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Intrapartum Caesarean delivery (ICD)
研究概览
简要总结
The progress of labour is traditionally determined by regular vaginal examinations (VEs) to assess the cervix (neck of the womb) and the baby's head position. Such examinations can be uncomfortable and risk causing infection to the baby or mother's womb. The findings are subjective, can be unreliable and cannot be recorded for later review and analysis.
The novel, non-intrusive "transperineal ultrasound" technique has been developed utilising existing scanning machines normally found on a delivery unit, with the ultrasound probe placed outside the woman's vagina. This allows objective, recordable measurements creating images that can be captured and stored electronically.
This is a prospective longitudinal observational cohort study in nulliparous term (37-42 weeks) labouring women. This study aims to improve the prediction of intrapartum Caesarean Delivery (ICD).
The study contains ultrasound and clinical assessments:
Transabdominal Ultrasound to measure: Umbilical and Middle Cerebral Artery Doppler, fetal head position and Amniotic Fluid Index (AFI).
Transperineal Ultrasound to assess: Head Perineum Distance (HPD), Caput Succedaneum and moulding.
Digital vaginal examination by a caregiver: to measure cervical dilatation.
Primary outcome:
• Mode of delivery
Secondary outcome:
• Time to delivery
Neonatal outcomes:
• Apgar score, cord pH level, gender, fetal birth weight, neonatal unit admission within 24 hours, neonatal morbidity.
详细描述
Intrapartum Caesarean Delivery (ICD) in advanced labour has a greater fetal and maternal morbidity and mortality than an elective prelabour Caesarean delivery. The prediction of delivery mode may reduce the likelihood of intrapartum Caesarean delivery. There is also a parental desire to know the likelihood of vaginal delivery. Women admitted to delivery units throughout the world undergo internal digital vaginal examination (DVE) when they are thought to be in labour or where a diagnosis of labour needs to be discounted. DVE is an uncomfortable experience, multiple examinations have been linked to ascending maternal and fetal infection, and it is subjective method and not reliable technique to assess labour progress.
It has recently become possible to make assessments more objectively using ultrasound. Ultrasound in labour (intrapartum ultrasound) has come to the forefront in the last decade stemming from a persistent demand for a more reliable method of labour assessment coupled with a wider availability of ultrasound on the delivery suite.
The hypothesise in this study, that developing the previously derived proof of principle labour prediction model for nulliparous women and using an additional data could improve the prediction accuracy of intrapartum Caesarean delivery by developing a robust model.
Using the additional data gathered in term nulliparous patients, will develop the model to predict pregnancy outcomes. This may aid in delivery of care to pregnant women by providing a real-time online calculation tool for the likelihood of Caesarean delivery and length of labour based on repeat ultrasound measurements.
All participants will be identified by the researcher and an emphasis will be placed on recruiting patients antenatally as much as possible. All participating patients will be consented prior to enrolment and will receive a full explanatory information leaflet. If recruited antenatally, there is no time limit until the woman enters the delivery unit. If recruited in labour, then 2 hours will be considered appropriate to make a decision on whether they wish to take part and patient will only be approached when relatively pain-free (in between contractions).
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
- •Cephalic presentation.
- •Nulliparous.
- •Singleton.
排除标准
- •Younger than 18 years.
- •Life-threatening maternal or fetal compromise needing immediate medical attention and/or delivery.
- •Women who in the opinion of the researcher are unable to give fully informed consent to the study.
- •Non-cephalic presentations.
- •Multiple pregnancies.
- •Multiparous patients.
- •Not in established labour
结局指标
主要结局
Intrapartum Caesarean delivery (ICD)
时间窗: 3 years
Number of participants who delivered by Caesarean section
次要结局
- Time to delivery (length of labour of onset of the first stage to the completion of the second stage).(12-24 hours)
