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临床试验/NCT01954186
NCT01954186已完成不适用

When and How to Administer Oxytocin for Active Management of Third Stage of Labour

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
试验地点
1
主要终点
postpartum bleeding in the third stage of labour

研究概览

简要总结

To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL).

详细描述

Our objective is to determine the most efficient route and timing of oxytocin administration by measuring the duration of third stage of labour, quantitative blood during the first hour after delivery and comparing haemoglobin and haematocrit changes and the need for additional interventions in patients who had either a spontaneous labour or received labour augmentation with oxytocin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Single (Participant)

入排标准

性别
Female
接受健康志愿者

入选标准

  • having a singleton pregnancy above 37th gestational week
  • normal live vaginal delivery with cephalic presentation
  • being in active labor

排除标准

  • Fetal demise
  • multiple pregnancy
  • known coagulation disorder
  • presentation anomalies
  • placental pathology
  • liver disease
  • thrombocytopenia
  • hypertension or being currently on anticoagulants
  • having a cesarean section, operative delivery or deep vaginal tear
  • chorioamnionitis
  • developing HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count) or DIC (disseminated intravascular coagulation) before delivery

研究组 & 干预措施

intravenous & intramuscular oxytocin

Experimental

intravenous or intramuscular 10 iu oxytocin

干预措施: after delivery of the fetus & when anterior shoulder seen (Procedure)

after delivery & when anterior shoulder seen

Active Comparator

oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered

干预措施: intravenous & intramuscular oxytocin (Drug)

结局指标

主要结局

postpartum bleeding in the third stage of labour

时间窗: participants will be followed for the duration of hospital stay, an expected average of 48 hours

次要结局

未报告次要终点

研究者

发起方
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
申办方类型
Unknown
责任方
Principal Investigator
主要研究者

SEZİN ERTURK AKSAKAL

gynecologist and obstetrician

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

研究点 (1)

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