Epidural Analgesia and Maternal Fever During Labor
- Conditions
- Analgesic EffectFeverEpidural Analgesia
- Interventions
- Drug: Epidural analgesia
- Registration Number
- NCT04940091
- Lead Sponsor
- Peking University First Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1051
- Age ≥18 years old;
- Nulliparae with single term cephalic pregnancy;
- Preparing to give vaginal delivery under epidural analgesia.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Epidural labor analgesia Epidural analgesia All participants will receive epidural analgesia during labor.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Neonatal Apgar score At 1 and 5 minutes after birth. Apgar score is assessed at 1 and 5 minutes after birth.
Postpartum hospital stay Up to 42 days after childbirth. Postpartum hospital stay
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.
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.
Trial Locations
- Locations (8)
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Dongguan women and children's hospital
🇨🇳Dongguan, Guangdong, China
Guangzhou Women and Children's Medical Center
🇨🇳Guangzhou, Guangdong, China
Tangshan maternal and child hospital
🇨🇳Tangshan, Hebei, China
Beijing Fuxing Hospital
🇨🇳Beijing, China
Beijing Haidian women and children's Hospital
🇨🇳Beijing, China
Xiamen maternal and child hospital
🇨🇳Xiamen, Fujian, China
Shijiazhuang Obstetric and Gynecology Hospital
🇨🇳Shijiazhuang, Hebei, China