The Giving Birth Project, a Study of Labor Dystocia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Labor outcome
研究概览
简要总结
Labor dystocia is an intransigent, high-profile issue in obstetric care, which causes significant maternal morbidity in low resource settings and maternal dissatisfaction, and increased healthcare costs worldwide. Amniotic fluid lactate, (AFL), values have recently been shown to reflect the metabolic status of the uterus and high levels have a strong association with subsequent need for operative intervention due to dystocia. In sports medicine, it is known that lactic acid can affect muscular performance but be decreased by bicarbonate given orally before physical activity. Main Outcome Measures: If an intake of bicarbonate, one hour before stimulation with oxytocin in cases with a high AFL value, changes the AFL levels and enhances delivery outcome in dystocic deliveries.
Design: Randomized controlled trial
详细描述
Primary question: whether high AFL values (>12mmol/l) in women with observed dystocic labor are best treated by
- to handle childbirth according to the clinic's current guidelines in case of labor dystocia, i.e. with oxytocin stimulation
- an intake of bicarbonate (Samarin) dissolved in water given 1 hour before the oxytocin is started Primary outcome variable A comparison of the frequency of spontaneous vaginal delivery in the observed two described intervention groups.
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
- •dystocic labor with a need of oxytocin >=34w of gestation
排除标准
- •Nondystocic labors.
- •Women who don't understand Swedish or English
- •Premature deliveries (<34w)
结局指标
主要结局
Labor outcome
时间窗: through study completion, an average of 1 year
Labor outcome in the different groups (spontaneous vaginal, VE or caesarean section)
AFL values
时间窗: through study completion, an average of 1 year
AFL-values to be at different times during labor
次要结局
- The use of oxytocin(through study completion, an average of 1 year)
研究者
Eva Wiberg-Itzel
Associate professor
Karolinska Institutet