Prediction of Uterine Atony After Vaginal Delivery by Shear Wave Elastography: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Stiffness of the myometrium
研究概览
简要总结
Prospective study evaluating the feasibility of shear-wave elastography of the uterus during the third stage of labour and following placental delivery. The investigators hypothesize that the stiffness of the myometrium can be measured by using shear-wave technology. This study involves 30 patients with a healthy pregnancy and spontaneous vaginal delivery. One co-investigator will carry out measurements at the uterine fundus, at three different time points: after fetal delivery, after placental delivery and 30 minutes after placental delivery.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •singleton pregnancy
- •cephalic presentation
- •maternal age > 18 years old
- •nulliparous
- •healthy uncomplicated pregnancy
- •gestational age between 37-42 weeks of gestation
- •spontaneous labour and delivery
- •uncomplicated progression of labour (cervical dilatation at >1 cm/h)
- •administration of less than 3 units of oxytocin during the second stage of labour
- •patient having read, accepted and signed the consent form
排除标准
- •antepartum hemorrhage in the present pregnancy
- •protracted second stage of labour (more than two hours from full dilatation to delivery)
- •more than 30 minutes of active pushing
- •BMI > 35 kg/m2
- •distance from skin to uterus > 8 cm
- •age > 35 years old
- •instrumental deliveries
- •bleeding disorders
- •polyhydramnios
- •pre-eclampsia
- •high blood pressure
- •use of anticoagulant medications
- •clinical chorioamnionitis
- •placental abnormality (low-lying or abruption)
- •fetal macrosomia
- •uterine fibroids
- •uterine anomalies
- •previous uterine scar
- •multiple pregnancy
- •placental retention
- •inability to follow procedures or insufficient knowledge of project language
- •inability to give consent
- •refusal to participate
结局指标
主要结局
Stiffness of the myometrium
时间窗: Third labor stage to 30 minutes post placenta delivery
Difference in median myometrial shear wave velocity between each time point: after fetal delivery, after placental delivery and 30 minutes after placental delivery.
次要结局
- Blood loss(Two hours following the childbirth)
研究者
DAVID DESSEAUVE
Principal investigator
Centre Hospitalier Universitaire Vaudois