Epidural Analgesia and Maternal Fever During Labor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Association Between the Effect of Epidural Analgesia and the Development of Maternal Fever During Labor: a Multicenter, Prospective, Observational, Cohort Study

Conditions
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Epidural Analgesia, Analgesic Effect, Fever

Intervention / Treatment
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* Drug: Epidural analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old; Nulliparae with single term cephalic pregnancy; Preparing to give vaginal delivery under epidural analgesia. Exclusion Criteria: Basal body temperature ≥37.3℃; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epidural labor analgesia<br>All participants will receive epidural analgesia during labor. | Drug: Epidural analgesia<br>* Epidural analgesia is performed with a mixture of local anesthetics (ropivacaine) and opioids (sufentanil).<br>* Other names: No other intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of maternal fever during labor | Maternal fever is defined as temperature of ≥38℃ during any stage of labor. | delivery ( the end of childbirth.) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of mild maternal fever during labor | Mild maternal fever is defined as temperature of >37.5℃ during any stage of labor. | delivery ( the end of childbirth.) | 
| Duration of labor | Duration of the first, second, and third stage of labor. | delivery ( the end of childbirth.) | 
| Neonatal Apgar score | Apgar score is assessed at 1 and 5 minutes after birth. | At 1 and 5 minutes after birth. | 
| Postpartum hospital stay | Postpartum hospital stay | Up to 42 days after childbirth. | 
| Postpartum pain intensity | Pain intensity is assessed with numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain). | At 1, 10 and 42 days after childbirth | 
| Postpartum breastfeeding | The status of breastfeeding include breastfeeding, formula milk, or a mix of them. | At 1, 10 and 42 days after childbirth | 
| Postpartum persistent pain | Defined as NRS pain score ≥1 that persisted since childbirth. For those with persistent pain, also ask if the following activities was affected, including walking, mood, sleep or concentration, as judged by parturients themselves. | At 42 days after childbirth | 
| Postpartum depression score | Postpartum depression is assessed with the the Edinburgh Postnatal Depression Scale. This is a 10-item self-report questionnaire; each item is rated from 0 to 3 denoting the increasing severity of symptoms, resulting in a maximum score of 30. A score ≥10 is defined as the presence of depression. | At 10 and 42 days postpartum | 
| Postpartum complications | Include maternal and neonatal complications, indicate new onset medical events that are harmful and required therapeutic intervention. | Up to 42 days postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural labor analgesia, Analgesic effect, Maternal fever during labor