Investigating how local anesthetic temperature affects maternal fever during childbirth
The Impact of Local Anesthetic Solution Temperature on Epidural-related Maternal Fever
NA · The First Affiliated Hospital of Soochow University · NCT06682416
This study tests whether using warmer or cooler local anesthetics during labor can help reduce the chances of mothers getting a fever while receiving epidural pain relief.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 424 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The First Affiliated Hospital of Soochow University (other) |
| Locations | 2 sites (Suzhou, Jiangsu and 1 other locations) |
| Trial ID | NCT06682416 on ClinicalTrials.gov |
What this trial studies
This study examines the effect of local anesthetic solution temperature on the incidence of maternal fever related to epidural analgesia during labor. It is a prospective, randomized controlled trial involving 424 participants from two hospitals. Participants will receive either 37°C or 23°C anesthetic solutions, and the study will measure fever rates, pain scores, and various maternal and neonatal outcomes. The research aims to clarify the relationship between anesthetic temperature and intrapartum fever, potentially improving pain management and reducing complications during childbirth.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 or older, at least 37 weeks of gestation, who are requesting epidural analgesia for vaginal delivery.
Not a fit: Patients who may not benefit from this study include those with contraindications to epidural analgesia, pre-existing fever, or multiple pregnancies.
Why it matters
Potential benefit: If successful, this study could lead to improved management of maternal fever during labor, enhancing safety and outcomes for both mothers and newborns.
How similar studies have performed: While the specific approach of manipulating local anesthetic temperature is novel, previous studies have indicated a significant incidence of maternal fever related to epidural analgesia, suggesting that this area of research is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Requesting epidural analgesia; 2. Aged 18 or older; 3. At least 37 weeks of gestation; 4. Those delivering vaginally. Exclusion Criteria: 1. Contraindications to epidural analgesia; 2. Pre-existing fever (≥38°C) before labor; 3. Use of NSAIDs or other types of antipyretics before labor; 4. Multiple pregnancy (carrying more than one fetus); 5. Fetal demise (stillbirth); 6. Severe preeclampsia; 7. Women who refuse to participate.
Where this trial is running
Suzhou, Jiangsu and 1 other locations
- Ethical Committee of the First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)
- Suzhou Municipal Hospital — Suzhou, Jiangsu, China (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Fuhai Ji — The First Affiliated Hospital of Soochow University
- Study coordinator: Dapeng Chen
- Email: hisoka52@outlook.com
- Phone: +8618550044050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epidural Related Maternal Fever, Analgesia, Epidural, Fever, Intrapartum Fever