Evaluation of the Efficiency of the Ultrasound Measure of the Thickness of the Lower Segment Associated With a Rule of Decision to Reduce the Foetal and Maternal Morbidity and Mortality in the Care of the Deliveries of the Women Having a History of Caesarian: a Pragmatic Randomized Trial : Lustrial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,955
- 试验地点
- 1
- 主要终点
- Composite criterion including maternal and neonatal parameters
研究概览
简要总结
The rate of caesarians dramatically increased for 15 years. The main indication of caesarian became the iterative caesarian of principle because of a history of caesarian. Any attempt of reduction of the rate of caesarians should thus focus on the indications of iterative principal caesarean. Nevertheless, the main reason usually evoked to justify a reduction of the attempts of low way after caesarian is the concern generated by the risk of uterine break during the trial of labor. Yet, there is no reliable method to predict this risk of uterine break. A way of interesting research consists in estimating the potential profits of the echography of the scar lower segment. Indeed, the echography can be useful to determine the specific risk of uterine break of a patient by measuring the thickness of the lower segment of the womb.
The strong negative predictive value of the echography of the lower segment on the risk of uterine break should encourage the women encircled to accept a trial of labor. That is why, this examination associated with a rule of decision could help to decrease the rate of iterative elective caesarians and especially to decrease the mortality and the foetal and maternal morbidity connected to the trial of labor among the patients having a history of caesarian.
详细描述
"Lower Uterine Segment Trial (LUSTrial)" Evaluation of the efficiency of the ultrasound measure of the thickness of the lower segment associated with a rule of decision to reduce the foetal and maternal morbidity and mortality in the coverage of the deliveries of the women having a history of caesarian: a pragmatic randomized trial
Aim Evaluation of the efficiency of the ultrasound measure of the thickness of the lower segment associated with a rule of decision to reduce the foetal and maternal morbidity and mortality in the coverage of the deliveries of the women having a history of caesarian Methodology Randomized trial, multicentric, open, in two parallel arms.
Evaluated treatments:
Between 36+0 and 38+6 weeks of amenorrhea, the patients will be invited to participate in the study. After agreement, the patients respecting the criteria of inclusion and not inclusion will be randomized in two groups:
GROUP A (experimental group) : The ultra sound measure of the thickness of the lower segment will be realized in a way standardized by expert sonographers. The patient will be informed that in case of measure:
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •unique pregnancy
- •gestational age between 36 SA and 38SA +6 days
- •cephalic presentation
- •lower uterine segment section's history
- •sign consent
排除标准
- •age < 18 years
- •history of longitudinal incision's caesarean
- •iterative caesarean indication
- •multiple pregnancy
- •placenta praevia
- •patient refuse trial of labor
- •absent consent
研究组 & 干预措施
Lower Uterine Segment Ultrasound
Measure of Uterine Segment by Ultrasound
干预措施: Ultrasound (Other)
control
no measure of Uterine Segment Ultrasound
结局指标
主要结局
Composite criterion including maternal and neonatal parameters
时间窗: at 3 days post partum
rupture uterine, uterine dehiscence, hysterectomy, deep venous thromboembolic complications, transfusion, endometritis, maternal mortality, foetal mortality antepartum, intrapartum foetal mortality, ischemic hypoxic encephalopathy, neonatal mortality
次要结局
- Rate of elective caesarean sections and of caesarean sections during labor(at 1 day post partum)
- Antepartum and intrapartum mortality(3 days post partum)
- Hypoxic-ischemic encephalopathy(at 3 days post partum)
- Uterine rupture(at 3 days post partum)
- Uterine dehiscence(at 3 days post partum)
- Thromboembolic complications(at 3 days post partum)
- Transfusion(at 3 days post partum)
- Hysterectomy(at 3 days post partum)
- Endometritis(at 3 days post partum)
- Perineal tears of the 3rd and 4th degree(at 1 day post partum)