Association Between the Effect of Epidural Analgesia and the Development of Maternal Fever During Labor: a Multicenter, Prospective, Observational, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,051
- 试验地点
- 8
- 主要终点
- Occurrence of maternal fever during labor
研究概览
简要总结
Women who receive epidural analgesia during labor are more likely to develop fever than those who do not. Maternal fever during labor can produce various harmful effects on both mothers and infants. The investigators speculate that the effect of epidural analgesia is associated with the development of maternal fever, i.e., better analgesia is associated with higher risk of maternal fever.
详细描述
Epidural related maternal fever (ERMF) refers to the phenomenon of increased body temperature of parturient after receiving epidural analgesia during labor. Women who receive epidural labor analgesia are more likely to have fever than those who do not. In a systematic review, 20-33% of parturients receiving neuraxial analgesia developed fever during labor, compared with only 5-7% of those without neuraxial analgesia. Maternal fever can interfere with women's laboring process, decrease the sensitivity of the uterus and cervix to oxytocin, and lead to dystocia and increased surgical delivery rate. The investigators note that the rate of ERMF is lower in patients receiving lower density neuraxial blockade. The study is designed to test the hypothesis that the effect of epidural analgesia is associated with the development of maternal fever, i.e., better analgesia is associated with higher risk of maternal fever.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •Nulliparae with single term cephalic pregnancy;
- •Preparing to give vaginal delivery under epidural analgesia.
排除标准
- •Basal body temperature ≥37.3°C;
- •Presence of serious pregnancy complications (such as severe preeclampsia, placenta accreta, HELLP [Hemolysis, Elevated Liver enzymes, Low Platelet count] syndrome, placenta previa, abruption of placenta, or hyperthyroidism);
- •History of hyperthyrodism, including hyperthyrodism in pregnancy;
- •Taking sedatives and/or analgesics within one week before planned delivery;
- •American Society of Anesthesiologists classification >class III;
- •Contraindications to epidural puncture, including central nervous system diseases (such as poliomyelitis), spinal diseases (such as intraspinal mass, lumbar disc herniation, history of spinal trauma, etc.), abnormal blood coagulation, etc.;
- •Presence of infections, including obstetric infections, systemic infections (such as sepsis, bacteremia), or infections at the puncture site or adjacent sites;
- •Other conditions that are considered unsuitable for study participation;
- •Refused to participate in the study.
研究组 & 干预措施
Epidural labor analgesia
All participants will receive epidural analgesia during labor.
干预措施: Epidural analgesia (Drug)
结局指标
主要结局
Occurrence of maternal fever during labor
时间窗: delivery ( the end of childbirth.)
Maternal fever is defined as temperature of ≥38℃ during any stage of labor.
次要结局
- Occurrence of mild maternal fever during labor(delivery ( the end of childbirth.))
- Duration of labor(delivery ( the end of childbirth.))
- Neonatal Apgar score(At 1 and 5 minutes after birth.)
- Postpartum hospital stay(Up to 42 days after childbirth.)
- Postpartum pain intensity(At 1, 10 and 42 days after childbirth)
- Postpartum breastfeeding(At 1, 10 and 42 days after childbirth)
- Postpartum persistent pain(At 42 days after childbirth)
- Postpartum depression score(At 10 and 42 days postpartum)
- Postpartum complications(Up to 42 days postpartum)
研究者
Dong-Xin Wang
Professor
Peking University First Hospital