An interventional study of In the context of epidural analgesia, the temperature of the local anesthetic solution is elevated to 37°C utilizing a blood transfusion and infusion warmer. in Epidural Related Maternal Fever, Analgesia, Epidural and Fever, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 2 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Prevention
This study investigates how the temperature of local anesthetics affects maternal fever related to epidural analgesia during childbirth. The research is a prospective, randomized controlled trial involving 424 participants from two hospitals. The primary objective is to investigate the impact of local anesthetic solution temperature on intrapartum fever in parturients. Secondary goals include assessing the impact on the efficacy of epidural analgesia and various maternal and neonatal outcomes. Participants will receive either 37°C or 23°C anesthetic solutions, and data will be collected on fever rates, pain scores, and other health indicators. The study runs from January 2024 to December 2026.
Background:
Maternal fever during labor is common, with an incidence of about 33%, often due to infection, epidural analgesia, or environmental factors. Multiple studies have indicated that the rate of intrapartum fever in women who receive epidural analgesia is approximately between 15% and 25%. After epidural analgesia, the risk of maternal fever significantly increases, a condition known as Epidural-Related Maternal Fever (ERMF). ERMF not only increases unnecessary antibiotic use but may also lead to unplanned cesarean sections, increased perinatal bleeding, and other complications. Moreover, any cause of intrapartum fever, including ERMF, can increase the incidence of neonatal brain injury by approximately 2.79 times. With the popularization of the concept of painless childbirth, ERMF has increasingly attracted people's attention. Despite being identified in 1989, the pathogenesis of ERMF remains unclear, with several mechanisms proposed, including infection, sympathetic blockade, and non-infectious inflammation induced by local anesthetics.
Methods:
This is a prospective randomized controlled study with 424 participants receiving epidural analgesia at two hospitals from October 2024 to October 2027. Participants will be randomly assigned to receive either 37°C or 23°C local anesthetic solutions. The study will measure maternal fever rates, the time for pain scores to decrease, and peripheral perfusion index at various intervals. Maternal and neonatal outcomes, including antibiotic usage, sepsis incidence, and Apgar scores, will be recorded.
Possible Conclusions:
The study aims to determine if the temperature of local anesthetics influences the incidence of ERMF. It also seeks to assess the impact of anesthetic temperature on the onset and duration of epidural analgesia and various maternal and neonatal health outcomes. The findings may provide evidence on whether warming local anesthetics can reduce the risk of ERMF and improve maternal and neonatal health during labor.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's planned enrollment of 424 is above the median of 123 across 271 interventional studies indexed under Fever.
Browse Fever studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 261 studies on the registry; 150 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be assigned to receive 37°C local anesthetic solutions.
Procedure: In the context of epidural analgesia, the temperature of the local anesthetic solution is elevated to 37°C utilizing a blood transfusion and infusion warmer.
Participants will be assigned to receive 23°C local anesthetic solutions.
For the observation group, after reactivating the analgesic pump's exhaust procedure to clear the air from the tubing, the output tubing of the analgesic pump is first connected to the epidural catheter. Following this, a blood transfusion and infusion warmer (manufactured by Barkey GmbH \& Co. KG., Germany, model S-line, with the national medical device registration number 20182450063) is used to preheat the output tubing of the analgesic pump until it reaches the predetermined temperature of 37°C. For the control group, after reactivating the analgesic pump's exhaust procedure to remove air from the tubing, the output tubing of the analgesic pump is connected to the epidural catheter without preheating the output tubing using a blood transfusion and infusion warmer, maintaining room temperature (23°C).
Maternal fever incidence
The primary outcome measure for this trial is the incidence of maternal fever, as determined by oral temperature readings, throughout the entire labor process. Maternal fever is defined as maternal intrapartum fever with a temperature of 38°C or higher.
Time frame: Before epidural catheterization, and at 2, 4, and 6 hours after epidural catheterization, and at the end of the second and third stages of labor, and 1 hour postpartum.
VAS ≤ 3
The Visual Analogue Scale (VAS) is a simple tool for assessing pain intensity. It features a 100mm line with "0" at one end indicating no pain and "10" at the other end representing the worst possible pain. Patients mark their pain level anywhere along the line, providing a continuous measure of their discomfort.
Time frame: From date of receiving epidural anesthesia until the date of VAS ≤ 3, an average of 30 minutes
Pulse Perfusion Index
Time frame: Before epidural anesthesia, and at 10 minutes, 20 minutes, and 30 minutes after epidural catheterization.
Maternal and Neonatal Antibiotic Use Rate
Querying the electronic medical record system for antibiotic usage
Time frame: From the date of randomization until the date of first documented maternal or neonatal antibiotic use, assessed up to 1 month postoperatively.
Incidence of bacteremia
The proportion of positive bacterial culture test results in each group.
Time frame: From the date of randomization until the date of first documented bacteremia, assessed up to 1 month postoperatively.
Intrapartum hypothermia
Time frame: Before epidural catheterization, and at 2, 4, and 6 hours after epidural catheterization, and at the end of the second and third stages of labor, and 1 hour postpartum.
Duration of labor
Time frame: From the onset of labor until the delivery of the placenta, assessed up to 48 hours.
Unplanned cesarean section rate
Time frame: From date of randomization until the delivery of the placenta, assessed up to 48 hours.
Umbilical Artery pH
After the delivery of the fetus, umbilical arterial blood is drawn to check the pH of the umbilical artery.
Time frame: up to 48 hours
Apgar score at 1st and 5th minute for newborns
After the delivery of the fetus, the Apgar score is assessed at the 1st and 5th minute post-delivery. The Apgar score is a quick test used to assess the physical condition of a newborn baby immediately after birth. It is performed at one and five minutes after birth, and sometimes at 10 and 20 minutes as well. The score is based on five criteria: Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration (breathing). Each category is scored on a scale from 0 to 2, with 0 indicating the worst condition and 2 the best. The total score ranges from 0 to 10, with a score of 7 to 10 generally considered normal, 4 to 6 indicating the need for some medical assistance, and below 4 requiring immediate medical attention.
Time frame: From the minute of fetal delivery until 5th minute post-delivery, assessed up to 5 minutes post-delivery.
Plan to share: Yes — We will share the raw data on ResMan (www.medresman.org.cn). Additionally, the research data will be published in the form of a paper within 2 years after the completion of the clinical trial.
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