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Search / Trial NCT06682416

The Impact of Local Anesthetic Solution Temperature on Epidural-related Maternal Fever

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Nov 8, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating how the temperature of local anesthetics used during epidural pain relief affects fever in mothers during childbirth. The study involves 424 women who are planning to have a vaginal delivery and want to use an epidural for pain management. Participants will be randomly assigned to receive either warmer (37°C) or cooler (23°C) anesthetic solutions. The main goal is to see if the temperature of the anesthetic influences the occurrence of fever during labor, while also looking at pain levels and other health outcomes for both mothers and their babies.

To be eligible for this study, women must be at least 18 years old, at least 37 weeks pregnant, and planning to have a vaginal delivery with an epidural. Certain conditions, such as having a fever before labor or carrying more than one baby, will exclude women from participating. If someone chooses to take part, they can expect to receive either the warmer or cooler anesthetic and will have their health monitored closely throughout the process. This study will run from January 2024 to December 2026, and it aims to provide valuable information about how the temperature of the anesthetic might impact maternal health during labor.

Gender

FEMALE

Eligibility 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.

About The First Affiliated Hospital Of Soochow University

The First Affiliated Hospital of Soochow University is a leading medical institution dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, the hospital leverages its extensive expertise in various medical disciplines to facilitate high-quality, ethically conducted studies that aim to enhance treatment options and improve patient outcomes. With a commitment to collaboration and scientific rigor, the institution plays a pivotal role in contributing to the global body of medical knowledge while ensuring the highest standards of patient care and safety.

Locations

Suzhou, Jiangsu, China

Suzhou, Jiangsu, China

Patients applied

0 patients applied

Trial Officials

Fuhai Ji

Principal Investigator

The First Affiliated Hospital of Soochow University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported