Bicarbonate, a New Treatment of Labour Dystocia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Frequency of spontaneous vaginal delivery
研究概览
简要总结
Dystocic deliveries and the use of bicarbonate
详细描述
A randomized controlled trial of 200 primiparous women in active labour.If cervical dilation crossed the action line in the partogram or if labour progress was arrested for two hours or more the delivery was considered to be dystocic, and Oxytocin was suggested for stimulation. Inclusion criteria were: primiparity, singleton pregnancy, with an arrested labour progress with a need for oxytocin. Gestational age was between 37-42 weeks, and no maternal /fetal chronic and/or pregnancy-related conditions. Excluded were multiparous women, deliveries with non-cephalic presentation, multiples, deliveries with fetal chronic and/or pregnancy-related conditions, IUFD (Intra Uterine Fetal Death) or premature < 37 weeks of gestation. A randomization into two groups was performed. One group was treated with two bags of Samarin® (=Samarin® group, 5g bicarbonate) one hour before stimulation with oxytocin started. The other group (=nonSamarin® group) received no bicarbonate and started oxytocin immediately, according to local clinical guidelines. Maternal and fetal data was collected from medical files after delivery and analysed according to group.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •primiparity, singleton pregnancy
- •with an arrested labour progress according to the partogram with a need for oxytocin
- •Gestational age was between 37-42 weeks
- •and no maternal /fetal chronic and/or pregnancy-related conditions.
排除标准
- •multiparous women
- •deliveries with non-cephalic presentation
- •multiples
- •deliveries with fetal chronic and/or pregnancy-related conditions
- •IUFD (Intra Uterine Fetal Death) or premature < 37 weeks of gestation
研究组 & 干预措施
Treatment
Dystocic women where bicarbonate was ingested
干预措施: Treatment (Dietary Supplement)
no treatment
Dystocic women where no bicarbonate was given
结局指标
主要结局
Frequency of spontaneous vaginal delivery
时间窗: during labor
次要结局
未报告次要终点
研究者
Eva Wiberg-Itzel
Associate professor, Senior lecturer
Karolinska Institutet
