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临床试验/NCT06550089
NCT06550089撤回2 期

A Pilot Study of High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth (HOLDOUT Pilot)

University of Chicago0 个研究点目标入组 100 人开始时间: 2024年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
入组人数
100
主要终点
Fidelity rate

研究概览

简要总结

This is a study to investigate whether it is feasible to conduct a randomized controlled trial (RCT) of a high dose of oxytocin versus the standard low-dose oxytocin. Further the investigators, aim to assess whether there are differences in health outcomes between both arms of the study.

详细描述

Due to risks of postpartum hemorrhage, defined by the American College of Obstetricians and Gynecologists, as an estimated or quantitative blood loss of greater than 1000 milliliters, uterotonics, or medications aimed at increasing uterine tone and reducing blood loss at the time of birth, are commonly administered. Based on a Cochrane network meta-analysis, most organizations endorse the administration of 10 international units (IU) of oxytocin during delivery. However, the World Health Organization specifies that during a cesarean birth, the 10 IU should be administered using a bolus dose and an infusion, though an optimal infusion rate has yet to be agreed upon.

The use of a higher rate of oxytocin may confer a reduction in overall blood loss and subsequent maternal health outcomes (e.g., postoperative anemia, hypotension) and healthcare resource utilization (e.g., need for additional uterotonics and surgical procedures to control bleeding, administration of blood products). However, it is unknown whether it is feasible to conduct a randomized controlled trial to investigate the use of high (i.e., oxytocin rate of 900 mL/hr immediately after the delivery of the placenta) versus low-dose oxytocin (i.e., 300 mL/hr for planned cesarean births or 600 mL/hr for intrapartum cesarean births).

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

High-dose oxytocin

Experimental

900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery

干预措施: Oxytocin (Drug)

Low-dose oxytocin

Active Comparator

For unlabored cesarean births: 300 mL/hr (18 IU/hr), with a maximum rate of 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery

For laboring cesarean births: 600 mL/hr (36 IU/hr), with a maximum rate of 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery

干预措施: Oxytocin (Drug)

结局指标

主要结局

Fidelity rate

时间窗: Within 8 hours prior to cesarean delivery

Frequency of fidelity to the trial

Acceptability of the intervention

时间窗: Up to 6 weeks after cesarean delivery

Frequency of acceptability of the intervention by both participants and their providers

Screen failure rate

时间窗: Within 8 hours prior to cesarean delivery

Number of individuals who are eligible for the study but do not consent to participate

Trial retention rate

时间窗: Up to 6 weeks after cesarean delivery

Frequency of participant completion of all study visits

次要结局

  • Surgical management of hemorrhage, inclusive of hysterectomy(During and up to 24 hours after cesarean delivery)
  • Myocardial ischemia(During and up to 24 hours after cesarean delivery)
  • Maternal hypotension(During and up to 6 hours after cesarean delivery)
  • Intensive care unit admission(During and up to 24 hours after cesarean delivery)
  • Readmission to the hospital or reoperation(Up to 6 weeks after cesarean delivery)
  • Maternal flushing(During and up to 6 hours after cesarean delivery)
  • Frequency of increase in oxytocin rate in low-dose arm(During and up to 6 hours after cesarean delivery)
  • Additional use of uterotonics and/or tranexamic acid(During and up to 24 hours after cesarean delivery)
  • Maternal nausea/vomiting(During and up to 6 hours after cesarean delivery)
  • Quantitative blood loss greater than 1 liter(Within 24 hours after cesarean delivery)
  • Need for blood product transfusion, inclusive of type and number of blood products transfused(Within 4 days after cesarean delivery)
  • Placement of intrauterine balloon tamponade or suction device(During and up to 24 hours after cesarean delivery)
  • Cardiac arrhythmia(During and up to 24 hours after cesarean delivery)
  • Maternal death(During and up to 6 weeks after cesarean delivery)

研究者

申办方类型
Other
责任方
Sponsor

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