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临床试验/EUCTR2012-000356-33-SE
EUCTR2012-000356-33-SE进行中(未招募)1 期

Prolonged labour with increased risk of cesarean section and negative birth experience is common among first-time mothers. Treatment today is continuous infusion of synthetic oxytocin. Knowledge is lacking, however regarding the optimal dosage. In this study, healthy primiparous women with normal pregnancy, spontaneous start and prolonged progress will receive either high or low dose of oxytocin. Frequency of cesarean delivery, infant health and women's childbirth experience will be examened.

未提供0 个研究点开始时间: 2013年1月22日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Inclusion criteria :
  • healthy nulliparous women with a normal singleton pregnancy at term (37+0 – 41+6 weeks) gestation with fetus in vertex presentation and spontaneous onset of labour
  • confirmed delay in labour and with ruptured membranes
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 1376
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range
  • Inclusion criteria :
  • healthy nulliparous women with a normal singleton pregnancy at term (37+0 – 41+6 weeks) gestation with fetus in vertex presentation and spontaneous onset of labour
  • confirmed delay in labour and with ruptured membranes
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 1376
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range
  • Inclusion criteria :
  • healthy nulliparous women with a normal singleton pregnancy at term (37+0 – 41+6 weeks) gestation with fetus in vertex presentation and spontaneous onset of labour
  • confirmed delay in labour and with ruptured membranes
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 1376
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Women under 18 years old,non-Swedish speaking women, women with previous uterine surgery, vaginal bleeding during labour of clinical significance, abnormal vertex presentation, fetal growth retardation > - 22 %, fetal heart rate abnormalities, heavy meconium staining, contra-indication to oxytocin therapy
  • Women under 18 years old,non-Swedish speaking women, women with previous uterine surgery, vaginal bleeding during labour of clinical significance, abnormal vertex presentation, fetal growth retardation > - 22 %, fetal heart rate abnormalities, heavy meconium staining, contra-indication to oxytocin therapy
  • Women under 18 years old,non-Swedish speaking women, women with previous uterine surgery, vaginal bleeding during labour of clinical significance, abnormal vertex presentation, fetal growth retardation > - 22 %, fetal heart rate abnormalities, heavy meconium staining, contra-indication to oxytocin therapy

研究者

发起方
未提供

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