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临床试验/NCT02805387
NCT02805387已完成不适用

Bicarbonate, a New Treatment of Labour Dystocia

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

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

Experimental

Dystocic women where bicarbonate was ingested

干预措施: Treatment (Dietary Supplement)

no treatment

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Wiberg-Itzel

Associate professor, Senior lecturer

Karolinska Institutet

研究点 (1)

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