Randomised Italian Sonography for Occiput POSition Trial Ante Vacuum
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,400
- 试验地点
- 2
- 主要终点
- failure rate of vacuum extraction in each of the two groups of patients included in the study (number of cesarean deliveries).
研究概览
简要总结
A failed operative vaginal delivery is associated with increased risk of maternal and perinatal complications. It is very important the determination of the fetal head position prior to instrumental delivery.
Generally,diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. There is a paucity of studies on the accuracy of digital examination but the general consensus is that reproducibility is low and diagnostic uncertainty remains high even for operators with much experience.
As the traditional clinical evaluation has many limitations, a new tool capable of increasing diagnostic objectivity and accuracy would be of great interest.
The aim of our study was to evaluate, in a prospective study, if the complementary use of ultrasound scan, to diagnose the fetal head position prior to instrumental delivery, may play a role in labor outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with singleton cephalic pregnancies at term (≥37 weeks' gestation), who require an instrumental delivery
排除标准
- •under 18 years of age
- •women with contraindications for vacuum delivery
- •women with sonography evaluation of fetal head position before randomization
- •fetal head station > +3
- •discretion of the responsible obstetrician in cases where there is urgency due to suspected fetal compromise("fetal distress")
结局指标
主要结局
failure rate of vacuum extraction in each of the two groups of patients included in the study (number of cesarean deliveries).
时间窗: 2 years
次要结局
- Incidence of: neonatal trauma (cephalhaematoma, retinal haemorrhage, facial nerve palsy, brachial plexus injury and fractures), low Apgar scores, fetal acidosis or admission to the neonatal unit, shoulder dystocia(2 years)
- Incidence of: primary postpartum haemorrhage, third and fourth degree perineal tears(2 years)
研究者
Tullio Ghi
Dr T. Ghi, Obstetrics and Prenatal Medicine Unit, University Hospital of Parma
University of Parma