NCT02954068已完成4 期
Intravenous Versus Intramuscular Administration of Oxytocin and Its Relationship With Postpartum Bleeding and Other Clinical Signs: a Randomized Placebo-controlled Study
Gynuity Health Projects1 个研究点 分布在 1 个国家目标入组 543 人开始时间: 2016年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 543
- 试验地点
- 1
- 主要终点
- Amount of blood loss (mL)
研究概览
简要总结
This double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection IM
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •She is present to give birth to a live fetus
- •Vaginal delivery
- •Willing to participate in the study
- •Able to give informed consent
排除标准
- •Scheduled for a cesarean
- •Reject the placement of an IV during labor (for intravenous infusion)
- •Cannot give informed consent for any reason
- •Not willing and / or cannot answer questions about background
研究组 & 干预措施
IV Infusion
Active Comparator
Oxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU
干预措施: IV Oxytocin + IM placebo (Drug)
IM administration
Active Comparator
Oxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml
干预措施: IM Oxytocin + IV placebo (Drug)
结局指标
主要结局
Amount of blood loss (mL)
时间窗: 1 hour postpartum
Proportion of women who had postpartum blood loss ≥500 ml
时间窗: 1 hour postpartum
次要结局
- Average time required until expulsion of the placenta(1 hour postpartum)
- Heart rate(15, 30, 45 and 60 minutes postpartum)
- Proportion of women who had postpartum blood loss ≥1000 ml(1 hour postpartum)
- Average change in hemoglobin level(pre-delivery and at least 24 hours postpartum)
- Side effects(1 hour postpartum)
- Proportion who needed additional Interventions(Through study completion, an average of 24-48 hours postpartum)
- Blood pressure(15, 30, 45 and 60 minutes postpartum)
研究者
研究点 (1)
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