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临床试验/NCT06354582
NCT06354582招募中4 期

Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia : A Randomized Controlled Trial

Kunyue Li1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年4月15日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Complete blood count indicators

研究概览

简要总结

This study aims to explore the effect of intravenous vitamin C infusion on intrapartum fever after epidural labor analgesia, to reduce the impact of intrapartum fever on maternal and infant, improve maternal and infant outcomes, and provide a reference for clinical preventive medication.

详细描述

Parturients who request pain relief would receive epidural labor analgesia after the obstetrician and anesthesiologist jointly evaluated and approved. The epidural catheter was inserted at the intervertebral space of either L2-3 or L3-4. 5 ml 1.5% chloroprocaine (with 1:200,000 epinephrine) as a test was delivered to parturients via the catheter. Then parturients would be observed for 5 min whether there were adverse reactions and then were given an initial dose of 10 ml ropivacaine 0.08% with sufentanil 0.3 µg/ml. After that, a patient-controlled epidural analgesia (PCEA) pump (240ml 0.08% ropivacaine with sufentanil 0.3 µg/ml) would be attached to the catheter. The pump would be set to administer an 8 ml bolus every 20 minutes and a 2 ml patient-controlled bolus with the same interval. Subsequently, trained nursing staff would take charge of the parturients and inform the obstetrician. The basic condition of parturients was monitored during the whole process. After that, parturients in each group will be administered vitamin C intravenously except the group for placebo-controlled.

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, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • single-fetus, head position, and full-term vaginal delivery receiving epidural labor analgesia.

排除标准

  • have a fever before epidural analgesia, acute infection on admission, incomplete baseline data, fatal fetal malformations or comorbidities, duration from admission to delivery of more than 72 hours or less than 3 hours, or an American Society of Anesthesiologists (ASA) classification of ≥ Ⅲ.

研究组 & 干预措施

Group C1

Experimental

The vitamin C1 group will receive 1 g of vitamin C intravenously administered after the induction of epidural labor anesthesia. The infusion speed will be set at 5ml/min.

干预措施: Vitamin C Injection (Drug)

Group C2

Experimental

The vitamin C2 group will receive 2 g of vitamin C intravenously administered after the induction of epidural labor anesthesia. The infusion speed will be set at 5ml/min.

干预措施: Vitamin C Injection (Drug)

Group C3

Experimental

The vitamin C3 group will receive 3 g of vitamin C intravenously administered after the induction of epidural labor anesthesia. The infusion speed will be set at 5ml/min.

干预措施: Vitamin C Injection (Drug)

Group P

Placebo Comparator

The control group P will receive normal saline and be administered after the induction of epidural labor anesthesia. The infusion speed will be set at 5ml/min.

干预措施: Normal saline (Other)

结局指标

主要结局

Complete blood count indicators

时间窗: Take blood test immediately before analgesia, immediately when parturients is developing intrapartum fever and immediately after delivery

Record the blood cell indicators for three times totally

Intrapartum fever or not

时间窗: Every two hours after receiving epidural labor analgesia, until baby delivery

The temperature of parturients ≥ 37.5℃

The temperature of parturients

时间窗: Every two hours after receiving epidural labor analgesia, until baby delivery.

After receiving epidural labor analgesia

The duration of intrapartum fever

时间窗: Every two hours after receiving epidural labor analgesia, until baby delivery.

If parturients develop intrapartum fever, record the lasting time of fever.

次要结局

  • the incidence of fetal distress(immediately After the baby is delivered)
  • Record the infant ward administration.(immediately After the baby is delivered)
  • Amount of total analgesics(immediately After the baby is delivered)
  • Incidence of rupture of membranes(immediately After the baby is delivered)
  • Visual analogue scale(VAS)(Every two hours after receiving epidural labor analgesia, until baby delivery.)
  • Side effects on mothers(immediately After the baby is delivered)
  • Delivery characteristics 2(immediately After the baby is delivered)
  • Record the weight of the baby.(immediately After the baby is delivered)
  • Record the gender of the baby.(immediately After the baby is delivered)
  • Apgar score(immediately After the baby is delivered)
  • the duration of total labor(immediately After the baby is delivered)

研究者

发起方
Kunyue Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kunyue Li

Principal Investigator

Third Affiliated Hospital of Zhengzhou University

研究点 (1)

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