Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Maternal Leucocytosis
研究概览
简要总结
This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes.
详细描述
It is a prospective, randomized trial to determine whether the use of sonographic parameters during childbirth results in less intrapartum infection compared to traditional invasive examination. Intrapartum non-invasive ultrasound has been established and validated as a method of assessing labor progress. Guidelines from international societies recommend the use of ultrasound to monitor labor and support decision-making during delivery. Despite its reproducibility and reliability, there is no comprehensive work to date demonstrating the potential benefit in reducing clinical chorioamnionitis compared to traditional invasive vaginal examination. With this in mind, the investigators set out to analyze the clinical benefit of using ultrasound alone using established non-invasive, intrapartum, translabial parameters (Angle of Progression, Head Perineum Distance, Midline Angle, Cervix Dilatation) to monitor birth outcomes compared to traditional invasive vaginal examinations.
Primary Outcome is the incidence of clinical chorioamnionitis. Secondary Outcome measures include mode of delivery and neonatal outcomes such as neonatal admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women of at least 18 years of age with a singleton in the cephalic position
- •Spontaneous onset of labor; births after induction of labor with otherwise suitable inclusion and exclusion criteria are also permitted.
排除标准
- •Emergency situations such as maternal or fetal bleeding
- •Indication for urgent delivery by caesarean section
- •Pathological cardiotocogram
- •non-cephalic positions
- •under 18 years of age
- •women giving birth who are unable to give consent
结局指标
主要结局
Maternal Leucocytosis
时间窗: In the course of labour from admission until delivery in 6 hour intervals
Percentage. Incidence of maternal leucocytosis (white blood cell count \>15,000 leukocytes per microliter of blood) in patients within the group
Maternal Tachycardia Incidence
时间窗: In the course of labour from admission until delivery in 3-4 hour intervals
Percentage. Incidence of \>100 beats per minute as maternal pulse measurement in patients within the group
Uterine tenderness
时间窗: In the course of labour from admission until delivery 3-4 hour intervals
Percentage. The incidence of uterine tenderness on palpation during the course of labour in patients within the group
Fetal Tachycardia
时间窗: In the course of labour from admission until delivery
Percentage.The incidence of fetal tachycardia (\>160 beats per minute) on continuous Cardiotocographic Monitoring in patients within the group
Maternal Fever Incidence
时间窗: In the course of labour from admission until delivery in 3-4 hour intervals
Percentage. Incidence of Fever \>37.8°C measured with a thermometer in patients within the group
Foul-smelling amniotic fluid
时间窗: In the course of labour from admission until delivery
Percentage . The incidence of foul-smelling amniotic fluid on clinical examination in patients with in the group
次要结局
- Average age(Upon admission for delivery)
- Incidence of estimated blood loss >1000 ml(In the course of labour until delivery and up to 24 hours postpartum)
- Incidence of Neonatal Admission(Up to 6 weeks postpartum)
- Incidence of Caesarean section(In the course of labour until delivery)
- Incidence of Instrumental Delivery(In the course of labour until delivery)
- Maternal weight(Upon admission for delivery)
- Maternal height(Upon admission for delivery)
- Previous pregnancy(Upon admission for delivery)
- Incidence of Vaginal Examinations(In the course of labour until delivery)
- Completed weeks of pregnancy(Upon admission for delivery)
- Maternal Satisfaction Scores(On admission and after delivery)
- Incidence of antibiotics usage(In the course of labour until delivery and up to 24 hours postpartum)
- Neonatal weight(Up to 30 Minutes after birth)
研究者
Larry Hinkson
Principal Investigator
Charite University, Berlin, Germany