Epidural Related Maternal FeverNCT06682416
The Impact of Local Anesthetic Solution Temperature on Epidural-related Maternal Fever
A study testing 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 people with Epidural Related Maternal Fever and Analgesia, Epidural, run by The First Affiliated Hospital of Soochow University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epidural Related Maternal Fever, Analgesia, Epidural, Fever
- What is being tested?
- 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.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 2 sitesChina
- Study dates
- 30 Nov 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requesting epidural analgesia;
- Aged 18 or older;
- At least 37 weeks of gestation;
- Those delivering vaginally.
Who cannot join
- Contraindications to epidural analgesia;
- Pre-existing fever (≥38°C) before labor;
- Use of NSAIDs or other types of antipyretics before labor;
- Multiple pregnancy (carrying more than one fetus);
- Fetal demise (stillbirth);
- Severe preeclampsia;
- Women who refuse to participate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Ethical Committee of the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Zhou-lin Lu, 008613914086271
- Not yet recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu
Lei Wei, +8613814874405, 64624369@qq.com
About this study
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.
Read the detailed description
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.
- Being tested
- 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.
- Medical subject headings
- Agnosia, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Experimental | Participants will be assigned to receive 37°C local anesthetic solutions. Receives: 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. |
| Control group | No intervention | Participants will be assigned to receive 23°C local anesthetic solutions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (9)
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.
Measured: From date of receiving epidural anesthesia until the date of VAS ≤ 3, an average of 30 minutes
Pulse Perfusion Index
Measured: 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
Measured: 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.
Measured: From the date of randomization until the date of first documented bacteremia, assessed up to 1 month postoperatively.
Intrapartum hypothermia
Measured: 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
Measured: From the onset of labor until the delivery of the placenta, assessed up to 48 hours.
Unplanned cesarean section rate
Measured: 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.
Measured: 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.
Measured: From the minute of fetal delivery until 5th minute post-delivery, assessed up to 5 minutes post-delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start30 Nov 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidural Related Maternal FeverStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuhai Ji, The First Affiliated Hospital of Soochow University
- Investigators
- Fuhai Ji, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682416
- Sponsor's protocol ID
- 2023367
- Status last verified
- Sep 2025
- First submitted
- 6 Nov 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Chen D, Wang Q, Wu Q, Shen M, Zhang J, Shan X, Feng CD, Tang H, Wei L, Ji F. Body-temperature versus room-temperature local anaesthetic solutions for epidural-related maternal fever prevention in labour: protocol for a two-centre randomised controlled trial. BMJ Open. 2025 Nov 4;15(11):e101760. doi: 10.1136/bmjopen-2025-101760.
PubMed 41193197
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Local Anesthetic Solution Temperature on Epidural-related Maternal Fever
- ClinicalTrials.gov ID
- NCT06682416
- Acronym / sponsor ID
- 2023367
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group | Experimental | 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 37°C local anesthetic solutions. |
| Control group | No intervention | –Participants will be assigned to receive 23°C local anesthetic solutions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Requesting epidural analgesia;
- Aged 18 or older;
- At least 37 weeks of gestation;
- Those delivering vaginally.
Key exclusion criteria (7 listed)
- Contraindications to epidural analgesia;
- Pre-existing fever (≥38°C) before labor;
- Use of NSAIDs or other types of antipyretics before labor;
- Multiple pregnancy (carrying more than one fetus);
- Fetal demise (stillbirth);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.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). | Procedure or surgery | Observation group |
Primary outcome
Maternal fever incidence
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.
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.
9 secondary outcomes
VAS ≤ 3
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
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
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
Time frame: up to 48 hours
Apgar score at 1st and 5th minute for newborns
Time frame: From the minute of fetal delivery until 5th minute post-delivery, assessed up to 5 minutes post-delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Derived from this study: PubMed 41193197Chen D, Wang Q, Wu Q, Shen M, Zhang J, Shan X, Feng CD, Tang H, Wei L, Ji F. Body-temperature versus room-temperature local anaesthetic solutions for epidural-related maternal fever prevention in labour: protocol for a two-centre randomised controlled trial. BMJ Open. 2025 Nov 4;15(11):e101760. doi: 10.1136/bmjopen-2025-101760.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fuhai Ji principal investigator
The First Affiliated Hospital of Soochow University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Epidural Related Maternal Fever and Analgesia, Epidural, run by The First Affiliated Hospital of Soochow University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dapeng Chen (+8618550044050, hisoka52@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal fever incidence (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06682416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.