Evaluation of the Modalities of Administration of Synthetic Oxytocin During Spontaneous Labor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,311
- 试验地点
- 1
- 主要终点
- Assessment of professional practices after the recommendations for clinical practice (RPC) published in December 2016, concerning the modalities of administration of synthetic oxytocin during physiological labor
研究概览
简要总结
Syntocinon was granted marketing authorization in France in 1970. Since the 1960s, it has been frequently used during childbirth, particularly in cases of stagnation of cervical dilatation due to a lack of uterine contractility. According to the latest National Perinatal Survey of 2010, 66.5% of patients go into labor spontaneously and 58% of them receive Syntocinon during labor.
The reported maternal effects associated with the use of synthetic oxytocin include uterine hyperactivity, postpartum hemorrhage (PPH) and severe PPH. The administration of oxytocin increases the risk of uterine hyperactivity in a dose-dependent manner. Regarding fetal risk, the reported adverse effects concern fetal heart rate abnormalities related to uterine hyperactivity. However, no study has shown an association between oxytocin administration and excess neonatal morbidity and mortality, except in the subpopulation of patients with a scarred uterus.
详细描述
In the 1950s, the speed of cervical dilation during labor was studied by Friedman. Dilatation is then divided into several phases:
- A first phase known as the latency phase which corresponds to the effacement of the cervix and its dilation up to 3 cm. It lasts on average 7 hours for a primipara and 5 hours for a multipara.
- A second active phase which corresponds to the dilation of the effaced cervix. This phase includes the progressive acceleration phase (up to 4-5 cm of dilation), a phase of maximum slope (up to 9 cm) and a deceleration phase where the slope decreases from 9 cm to full dilation (FD). This active phase lasts, on average, 4h30 in primiparous women and 2h30 in multiparous women.
Friedman concluded that cervical dilatation should be of the order of 1.5 cm/h and more in the active phase and that it should not fall below 1 cm/h in nulliparous women and 1.5 cm/h in multiparous women.
In the 1980s, the use of syntocinon became commonplace.Under the influence of an Irish physician, O'Driscoll, policies of quasi-systematic direction of labor were implemented, in particular in nulliparous women. This concept of active management of labor was developed in response to the observation of a high rate of cesarean sections performed for stagnation. This active labor management included systematic rupture of membranes (amniotomy) and infusion of Syntocinon when the dilation rate was less than 1 cm/h.
Beginning in the 2000s, Zhang also focused on the physiological duration of labor. He showed that a so-called normal labor could be much longer than previously described, especially before 6cm of cervical dilation. In 2010, he proposed a new partogram for nulliparous patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Major patient
- •Single pregnancy
- •Non-scarring uterus
- •Fetus estimated to be eutrophic in prenatal
- •Cephalic presentation
- •Spontaneous labor from 37 weeks of amenorrhea
排除标准
- •Patient under guardianship or curatorship
- •Patient deprived of liberty
- •Patient objecting to the use of her data for this research
结局指标
主要结局
Assessment of professional practices after the recommendations for clinical practice (RPC) published in December 2016, concerning the modalities of administration of synthetic oxytocin during physiological labor
时间窗: Day 1
Difference in management modalities between two groups of patients: * A first group of patients who gave birth in 2016 * A second group of patients who gave birth in 2018
Assessment of professional practices before the recommendations for clinical practice (RPC) published in December 2016, concerning the modalities of administration of synthetic oxytocin during physiological labor
时间窗: Day 1
Difference in management modalities between two groups of patients: * A first group of patients who gave birth in 2016 * A second group of patients who gave birth in 2018
次要结局
- Evaluation of the impact of the application of the new recommendations on the rate of vaginal deliveries(Day 1)
- Evaluation of the impact of the application of the new recommendations on the rate of neonatal morbidity(Day 1)
- Evaluation of the impact of the application of the new recommendations on the rate of postpartum hemorrhage(Day 1)