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临床试验/NCT03232918
NCT03232918招募中4 期

A Randomized Controlled Trial Evaluating the Effect of the Oxytocin Infusion Rate on Fetal Heart Rate Changes and Maternal-Fetal Outcomes During the Initiation of Combined Spinal-Epidural Labor Analgesia

Unyime Ituk2 个研究点 分布在 1 个国家目标入组 730 人开始时间: 2019年2月20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
招募中
发起方
入组人数
730
试验地点
2
主要终点
Incidence of non-reassuring fetal heart rate tracings

研究概览

简要总结

The reported risk of nonreassuring fetal heart trace following neuraxial analgesia is 3-23%. This variability may be due to fluid and oxytocin management prior to and during the initiation of neuraxial analgesia. The study hypothesis is that decreasing the oxytocin infusion rate by 50 % prior to initiation of combined spinal epidural analgesia will cause a reduction in the incidence of adverse fetal heart rate changes.

详细描述

Oxytocin is used in labor and delivery to increase the frequency of contractions and augment uterine contractile strength, thereby establishing a regular pattern of labor. However, the administration of exogenous oxytocin in the presence of an uncoordinated labor pattern confers a risk for an increase in uterine contraction frequency, resulting in inadequate relaxation periods. This leads to an increase in the basal tone of the uterus, which may lead to a tetanic contraction with the risk of decreased uteroplacental blood flow and fetal hypoxemia. Previous studies investigating low- versus high-dose oxytocin for induction or augmentation of labor have had conflicting results on the effect on fetal heart rate abnormalities. One of the limitations of these studies is that the labor analgesia was not standardized. The combination of low-dose combined spinal epidural analgesia and the high/low dose oxytocin have not been evaluated. One of the proposed mechanisms for nonreassuring fetal heart a tracing after initiation of analgesia is that the pain relief from neuraxial analgesia causes a decrease in catecholamine release by the sympathetic nervous system. The subsequent decrease in the circulating epinephrine concentration contributes to an increase in uterine tone, as epinephrine is a potent tocolytic agent. The increased tone, in turn, leads to a decrease in placental blood flow, and eventually fetal bradycardia. The primary outcome of this study is the incidence of non-reassuring fetal heart rate tracings within the first 60 minutes after the placement of combined spinal epidural analgesia

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The labor room nurse will be aware of the patient group assignment and will adjust the dose of the drug based on group assignment. The Investigator, Physician Provider and Outcome Assessor will be blinded.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy nulliparous or multiparous women at term (37 > weeks' gestation)
  • Singleton pregnancy
  • Request for neuraxial analgesia
  • Oxytocin used for induction of labor or augmentation of labor per institutional protocols

排除标准

  • Use of chronic analgesic medications
  • Prior administration of systemic opioid labor analgesia
  • Non-vertex presentation
  • Contraindication to neuraxial analgesia
  • Category 3 fetal heart rate tracing prior to the initiation of combined spinal epidural analgesia

研究组 & 干预措施

Half Dose Oxytocin

Experimental

Patients randomized to the half dose oxytocin will have their oxytocin infusion reduced by 50 % prior to placement of a combined spinal epidural for labor analgesia.

干预措施: Half dose Oxytocin (Drug)

结局指标

主要结局

Incidence of non-reassuring fetal heart rate tracings

时间窗: 1.5 hours

Fetal heart rate tracings will be examined for 30 minutes before and 60 minutes after the initiation of combined spinal epidural analgesia

次要结局

  • Effect of oxytocin dose on duration of 1st and 2nd stage of labor(24 hours)
  • Mode of delivery(24 hours)

研究者

发起方
Unyime Ituk
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Unyime Ituk

Associate Professor

University of Iowa

研究点 (2)

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