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临床试验/NCT04017247
NCT04017247已完成不适用

A Comparison Between Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2019年11月1日最近更新:
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
入组人数
153
试验地点
1
主要终点
Delivery within 24 hours

研究概览

简要总结

The study will compare 2 treatment modalities. One group will receive the routine protocol of intermittent pitocin induction for 6 hours and the second group will receive continous pitocin infusion for 16 hours.

The primary aim is to observe which protocol leads to the fastest delivery and evaluate the time in each group from induction to delivery.

详细描述

After singing an informed consent, and prior to IOL initiation, study participants were randomly assigned (1:1) to receive either intermittent or continuous Oxytocin infusion. Both groups received the same primary infusion dose of Oxytocin 1.0 with an incremental increase of 2.5 every 30 minutes until 20, titered to a target of 3-5 contractions in a 10 minute period. During Oxytocin infusion, fetal heart rate was continuously monitored. Artificial ROM was performed according to the accepted indications, local protocol and by the staff physician discretion who was in charge on the labor ward at that time, regardless of oxytocin initiation time. In the intermittent Oxytocin infusion group, Oxytocin was discontinued after 8 h if the patient did not go into active labor during by that time, and renewed 4 h later. In the continuous infusion group, patients received a continuous Oxytocin infusion for 16 h. If they did not go into active labor within this frame time, Oxytocin was discontinued for 4 hours and then resumed. In addition, during Oxytocin infusion, sodium levels were monitored every 8 h.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with a singleton pregnancy that are admitted for induction or augmentation of labor.
  • Women at gestational age 370/7 or more.
  • Vertex presentation.

排除标准

  • Age under 18 or over
  • High order gestation.
  • Women with contraindication for vaginal delivery.
  • Active labor.
  • Women with a uterine scar.
  • Multiparity(> 5 deliveries).
  • Documented fetal anomalies.

研究组 & 干预措施

Intermittent treatment

Active Comparator

Infusion of oxytocin for 6 hours at a time until patient delivers.

干预措施: Oxytocin (Drug)

Continous treatment

Active Comparator

Infusion of oxytocin continuously from patient admission for 16 hours.

干预措施: Oxytocin (Drug)

结局指标

主要结局

Delivery within 24 hours

时间窗: from admission up to 24 hours postpartum

The percentage of women delivering within 24 hours.

次要结局

  • caesarian deliveries(from admission up to 24 hours postpartum)
  • latent phase of labor.(from admission up to 24 hours postpartum)
  • instrumental deliveries(from admission up to 24 hours postpartum)
  • active phase of labor.(from admission up to 24 hours postpartum)

研究者

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

ROY LAUTERBACH MD

Principal Investigator

Rambam Health Care Campus

研究点 (1)

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