Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia : A Randomized Controlled Trial
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
- 是
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
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
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
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
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
Kunyue Li
Principal Investigator
Third Affiliated Hospital of Zhengzhou University
