Analgesic Effect, Epidural Analgesia, Fever
Conditions
Keywords
Epidural labor analgesia, Analgesic effect, Maternal fever during labor
Brief summary
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
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.
Interventions
DRUGEpidural analgesia
Epidural analgesia is performed with a mixture of local anesthetics (ropivacaine) and opioids (sufentanil).
Sponsors
Guangdong Women and Children Hospital
Tangshan Maternal and Child Health Hospital
Dongguan Maternal and Child Health Hospital
Beijing Haidian Maternal and Child Health Hospital
Beijing Fuxing Hospital
The Fourth Hospital of Shijiazhuang
Xiamen Maternity & Child Care Hospital
Peking University First Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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°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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of maternal fever during labor | delivery ( the end of childbirth.) | Maternal fever is defined as temperature of ≥38℃ during any stage of labor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum pain intensity | At 1, 10 and 42 days after childbirth | Pain intensity is assessed with numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain). |
| Postpartum breastfeeding | At 1, 10 and 42 days after childbirth | The status of breastfeeding include breastfeeding, formula milk, or a mix of them. |
| Occurrence of mild maternal fever during labor | delivery ( the end of childbirth.) | Mild maternal fever is defined as temperature of \>37.5℃ during any stage of labor. |
| Duration of labor | delivery ( the end of childbirth.) | Duration of the first, second, and third stage of labor. |
| Postpartum hospital stay | Up to 42 days after childbirth. | Postpartum hospital stay |
| Postpartum persistent pain | At 42 days after childbirth | 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. |
| Postpartum depression score | At 10 and 42 days postpartum | 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. |
| Postpartum complications | Up to 42 days postpartum | Include maternal and neonatal complications, indicate new onset medical events that are harmful and required therapeutic intervention. |
| Neonatal Apgar score | At 1 and 5 minutes after birth. | Apgar score is assessed at 1 and 5 minutes after birth. |
Countries
China
Outcome results
None listed