Alternative to Intensive Management of the Active Phase of the Second Stage of Labor : a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,701
- 试验地点
- 2
- 主要终点
- Neonatal morbidity composite measure
研究概览
简要总结
Active phase of the second stage of labor corresponds to period of maternal expulsive efforts (i.e. pushing). An intensive management of this phase is usual in France. This study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of delivery.
详细描述
Management of the active phase of the second stage of labor is not an evidence-based practice. Management of this phase differs between countries. In France, national guidelines recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians (midwives and obstetricians) encourage usually women to push 3 times per contractions and to push on every contraction in order to deliver into a 30 minutes timing.
This study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of delivery. In the intervention group, i.e. "moderate" pushing, women are encouraged to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.
The hypothesis is that "moderate" management of the active phase of the second stage allows decreasing frequency of neonatal morbidity at birth, decreasing frequency of operative delivery and increasing maternal satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •primiparous women
- •singleton fetus
- •fetal cephalic presentation
- •≥37 gestational weeks
- •living fetus
- •Patient with epidural analgesia
- •Major Female
- •Women understand French
排除标准
- •Abnormal fetal heart rate requiring hastening childbirth
- •cervical dilatation < 8 cm
- •intrauterine fetal growth restriction <5e percentile,
- •Fetal malformation,
- •history of gynecological surgery with uterine scar
- •Women do not understand French,
- •women with psychiatric condition
- •contraindication to intensive management of active second stage (severe myopia, respiratory or cardiac failure)
- •no affiliation to a social security scheme (beneficiary or assignee)
研究组 & 干预措施
"Moderate" management
Women are encouraged by physicians to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.
干预措施: "Moderate" management (Procedure)
"Intensive" management
Usual obstetrical care in France
干预措施: "Intensive" management (Procedure)
结局指标
主要结局
Neonatal morbidity composite measure
时间窗: at childbirth
number of participant with acidosis arterial cord pH \<7.15 and / or excess base\> 10 mmol / L and / or lactate\> 6 mmol / L and or an Apgar score at 5 minutes \<7 and or severe neonatal trauma defined by fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure) and or an Apgar score at 5 minutes \<7 and or severe neonatal trauma: fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure)
次要结局
- Immediate postpartum complications(2 hours after delivery)
- Urinary and anal incontinence assessed with the Wexner Score(6 months post partum)
- Women satisfaction assessed with the ICIQ-UI Short Form(6 months post partum)
- Mode of delivery(at childbirth)
- Women satisfaction assessed with the Labour Agentry scale(2 hours after delivery)