Clinical trial NCT04940091: Epidural Analgesia and Maternal Fever During Labor
Official title: Association Between the Effect of Epidural Analgesia and the Development of Maternal Fever During Labor: a Multicenter, Prospective, Observational, Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidural Analgesia
Analgesic Effect
Fever
Keywords: Epidural labor analgesia
Analgesic effect
Maternal fever during labor
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Guangdong Women and Children Hospital
name: Tangshan Maternal and Child Health Hospital
name: Dongguan Maternal and Child Health Hospital
name: Beijing Haidian Maternal and Child Health Hospital
name: Beijing Fuxing Hospital
name: Fourth Hospital of Shijiazhuang City
name: Xiamen Maternity & Child Care Hospital
First posted: 2021-06-25
Enrollment: 1051
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult (≥18 years old) nulliparae with single term cephalic pregnancy preparing to give vaginal delivery under epidural analgesia.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of maternal fever during labor
timeFrame: delivery ( the end of childbirth.)
Secondary outcomes:
measure: Occurrence of mild maternal fever during labor
timeFrame: delivery ( the end of childbirth.)
measure: Duration of labor
timeFrame: delivery ( the end of childbirth.)
measure: Neonatal Apgar score
timeFrame: At 1 and 5 minutes after birth.
measure: Postpartum hospital stay
timeFrame: Up to 42 days after childbirth.
measure: Postpartum pain intensity
timeFrame: At 1, 10 and 42 days after childbirth
measure: Postpartum breastfeeding
timeFrame: At 1, 10 and 42 days after childbirth
measure: Postpartum persistent pain
timeFrame: At 42 days after childbirth
measure: Postpartum depression score
timeFrame: At 10 and 42 days postpartum
measure: Postpartum complications
timeFrame: Up to 42 days postpartum
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Xiamen
country: China
facility: Xiamen maternal and child hospital
state: Fujian
city: Dongguan
country: China
facility: Dongguan women and children's hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Shijiazhuang
country: China
facility: Shijiazhuang Obstetric and Gynecology Hospital
state: Hebei
city: Tangshan
country: China
facility: Tangshan maternal and child hospital
state: Hebei
city: Beijing
country: China
facility: Beijing Fuxing Hospital
city: Beijing
country: China
facility: Beijing Haidian women and children's Hospital
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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