An observational study in Epidural Analgesia, Analgesic Effect and Fever, sponsored by Peking University First Hospital. Completed at 8 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Peking University First Hospital · Observational
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.
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.
601 studies on the registry are indexed under Fever; 101 are open to participants now.
This study's enrollment of 1,051 is above the median of 200 across 188 observational studies indexed under Fever.
Browse Fever studies →Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
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Adult (≥18 years old) nulliparae with single term cephalic pregnancy preparing to give vaginal delivery under epidural analgesia.
Exclusion Criteria:
All participants will receive epidural analgesia during labor.
Drug: Epidural analgesia
Epidural analgesia is performed with a mixture of local anesthetics (ropivacaine) and opioids (sufentanil).
Also known as: No other intervention
Occurrence of maternal fever during labor
Maternal fever is defined as temperature of ≥38℃ during any stage of labor.
Time frame: delivery ( the end of childbirth.)
Occurrence of mild maternal fever during labor
Mild maternal fever is defined as temperature of \>37.5℃ during any stage of labor.
Time frame: delivery ( the end of childbirth.)
Duration of labor
Duration of the first, second, and third stage of labor.
Time frame: delivery ( the end of childbirth.)
Neonatal Apgar score
Apgar score is assessed at 1 and 5 minutes after birth.
Time frame: At 1 and 5 minutes after birth.
Postpartum hospital stay
Postpartum hospital stay
Time frame: 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).
Time frame: At 1, 10 and 42 days after childbirth
Postpartum breastfeeding
The status of breastfeeding include breastfeeding, formula milk, or a mix of them.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 42 days postpartum
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Peking University First Hospital