Epidural-related maternal fever: incidence, pathophysiology, outcomes, and management.
Selina Patel, Sarah Ciechanowicz, Yair J Blumenfeld...
https://pubmed.ncbi.nlm.nih.gov/36925412Actively Recruiting
Phase 4
Age: 18Years - 35Years
FEMALE
Healthy Volunteers
ID06354582
Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia: A Randomized Controlled Trial
Led by Kunyue Li · Updated on 2024-07-03
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Kunyue Li
Lead Sponsor
T
Third Affiliated Hospital of Zhengzhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to explore how intravenous vitamin C infusion affects the occurrence of fever during labor in women who receive epidural pain relief. The study focuses on reducing fever-related impacts on both mothers and infants to improve their health outcomes and offers guidance for clinical preventive treatments. It is a phase 4 randomized controlled trial involving women experiencing labor complications and fever. Participants will receive epidural labor analgesia through a catheter placed in the lower spine, with an initial test dose followed by a continuous patient-controlled epidural analgesia pump. After the epidural anesthesia is started, participants are randomly assigned to receive either 1 g, 2 g, or 3 g of vitamin C intravenously, or a placebo of normal saline, all infused at a rate of 5 ml per minute. During the study, maternal temperature and fever status are monitored every two hours until delivery. Blood tests are taken before analgesia, when fever develops, and after delivery. Researchers will also assess pain levels, total analgesic use, delivery details, and newborn health immediately after birth. The study includes safety monitoring and records infant care needs, with participation lasting through labor and delivery.
CONDITIONS
Brief Title
Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia
Who Can Participate
Age: 18Years - 35Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Female parturients aged 18 to 35 years
- Single fetus in head position
- Full-term vaginal delivery planned
- Receiving epidural labor analgesia
You will not qualify if you...
- Fever before epidural analgesia
- Acute infection at admission
- Incomplete baseline data
- Fatal fetal malformations or comorbidities
- Admission to delivery duration less than 3 hours or more than 72 hours
- American Society of Anesthesiologists (ASA) classification 3 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 72 hours or until delivery
Participants receive epidural labor analgesia followed by intravenous administration of vitamin C or placebo. Their condition and pain relief are monitored during labor.
Continuous monitoring during labor with assessments every 2 hours
Follow-up
Duration - Immediately after delivery
After delivery, participants are evaluated for side effects, labor and delivery outcomes, and newborn health.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
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Research Team
K
Kunyue Li, M.M
T
Tao Wang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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Published Research Related To This Trial
Epidural-Related Maternal Fever: Still a Hot Topic, But What Are the Burning Issues?
Pervez Sultan, Scott Segal
https://pubmed.ncbi.nlm.nih.gov/31934906Severity of intrapartum fever and neonatal outcomes.
Drew Hensel, Fan Zhang, Ebony B Carter...
https://pubmed.ncbi.nlm.nih.gov/35598690Epidural analgesia, intrapartum hyperthermia, and neonatal brain injury: a systematic review and meta-analysis.
Sarah Morton, Justin Kua, Christopher J Mullington
https://pubmed.ncbi.nlm.nih.gov/33218673