Reducing Neonatal Morbidity by Discontinuing Oxytocin During the Active Phase of 1st Stage of Labor: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,459
- 试验地点
- 1
- 主要终点
- neonatal morbidity composite measure
研究概览
简要总结
The purpose of this study is to measure the impact of a discontinuous administration of oxytocin during the active phase of the 1st stage of labor on the neonatal morbidity rate.
The investigators hypothesize that discontinuation of oxytocin in the active phase of labor (from 6 cm) in women who received oxytocin in the latent phase or for an induction (before 4 cm of dilation) could reduce neonatal morbidity.
详细描述
Oxytocin is effective in increasing frequency and intensity of uterine contractions and therefore in reducing the duration of labor. Nevertheless, its administration is potentially associated with fetal and maternal short-and long- term complications, such as neonatal acidosis and post-partum hemorrhage and its effectiveness in decreasing caesarean section rate has not been clearly demonstrated.
The most important side effect of oxytocin infusion is uterine hyper-stimulation, which has been shown to occur in more than 30% of women induced with oxytocin. By causing uterine hyper-stimulation, oxytocin infusion may lead to or aggravate abnormal fetal heart rate, contributing to neonatal acidosis. Acidosis is a major part of neonatal morbidity due to related complications such as hospitalization in neonatal intensive care units, but also neonatal death or cerebral palsy in the most severe cases.
The first stage of labor is divided into two phases, a latent phase where cervical dilation is relatively slow until 5-6 cm and an active phase until full dilatation, where cervical dilation accelerates. Currently in France, when oxytocin administration has been initiated during the latent phase, the standard care is to continue it during the whole duration of labor. One assumption is that, once women requiring oxytocin during the latent phase enter the active phase, natural oxytocin takes over from synthetic oxytocin. Thus, in the active phase, oxytocin could be discontinued, reducing exposure duration and therefore reducing the risk of complications, in particular neonatal complications, without compromising the chances of vaginal delivery.
It can therefore be hypothesized that discontinuation of oxytocin in the active phase of labor (from 6 cm) in women who received oxytocin in the latent phase or for an induction (before 4 cm of dilation) could reduce neonatal morbidity.
Several small trials attempting to evaluate this practice have been published, but their design and small population did not allow evaluating the impact of discontinuation of oxytocin on neonatal morbidity. Thus, the investigators propose to conduct a large randomized controlled trial, STOPOXY, aiming to reduce oxytocin exposure and its adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •With a term (≥37 WG) pregnancy
- •Singleton pregnancy
- •Fetus in cephalic presentation
- •Women receiving oxytocin during the latent phase of the 1st stage of labor, before 4 cm of cervical dilatation, including women with an induction of labor using cervical ripening or oxytocin
- •Speaking and reading French language
- •Affiliated to social security
- •Who have signed the consent form
排除标准
- •Women with a scarred uterus
- •Fetus with a congenital anomaly
- •Fetal growth retardation <3rd percentile
- •Having an abnormal fetal heart rate at randomization
- •Maternal age < 18 years
- •Participating in another trial involving medication
研究组 & 干预措施
discontinuation of oxytocin administration
Discontinuation of oxytocin administration at the beginning of the active phase of the 1st stage of labor, i.e. oxytocin infusion will be stopped beyond a cervical dilatation of 6cm
干预措施: discontinuation of oxytocin administration (Drug)
continuation of oxytocin administration
Standard care in France, i.e. when oxytocin is started during the latent phase of the 1st stage, administration of oxytocin is continued during the active 1st stage and during the 2nd stage if the fetal heart rate is reassuring.
干预措施: continuation of oxytocin administration (Drug)
结局指标
主要结局
neonatal morbidity composite measure
时间窗: At birth
Neonatal morbidity will be assessed using a composite variable defined by: an umbilical arterial pH at birth \<7.10 and/or a base excess \>10mmol/L and/or umbilical arterial lactates\>7 mmol/L and/or a 5 minutes Apgar score \<7 and/or admission in neonatal intensive care unit (NICU). This composite outcome is based on pertinent and previously published thresholds to assess neonatal acidosis\[16\]
次要结局
- umbilical cord pH<7.00(At birth)
- neonatal admission(2 hours postpartum)
- umbilical cord pH<7.20(At birth)
- umbilical cord pH<7.10(At birth)
- length of the newborn's hospital stay(0-1 month)
- Need for hypothermia(At birth)
- other neonatal complications:(2 hours postpartum)
- labor duration(0-48hours)
- uterine hyper-stimulation(0-48hours)
- maternal hyperthermia(0-48hours)
- fetal occipito-posterior position(0-48hours)
- fetal scalp blood testing(0-48hours)
- postpartum hemorrhage(0-48hours)
- The post-partum women's satisfaction: labor agentry scale(at 2 months postpartum in a survey)
- mode of delivery(0-48hours)
- The post-partum women's satisfaction(at 2 months postpartum in a survey)
- The post-partum women's satisfaction(0 5 day)