Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia

Fever Clinical Trial

— EIVCIMFAELA  

Official title:

Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia : A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06354582
• Other study ID #: 2024-085-01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2024
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Third Affiliated Hospital of Zhengzhou University
• Contact: Kunyue Li, M.M
• Phone: +8615836298766
• Email: likunyue0312[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to explore the effect of intravenous vitamin C infusion on intrapartum fever after epidural labor analgesia, to reduce the impact of intrapartum fever on maternal and infant, improve maternal and infant outcomes, and provide a reference for clinical preventive medication.

Description:

Parturients who request pain relief would receive epidural labor analgesia after the obstetrician and anesthesiologist jointly evaluated and approved. The epidural catheter was inserted at the intervertebral space of either L2-3 or L3-4. 5 ml 1.5% chloroprocaine (with 1:200,000 epinephrine) as a test was delivered to parturients via the catheter. Then parturients would be observed for 5 min whether there were adverse reactions and then were given an initial dose of 10 ml ropivacaine 0.08% with sufentanil 0.3 µg/ml. After that, a patient-controlled epidural analgesia (PCEA) pump (240ml 0.08% ropivacaine with sufentanil 0.3 µg/ml) would be attached to the catheter. The pump would be set to administer an 8 ml bolus every 20 minutes and a 2 ml patient-controlled bolus with the same interval. Subsequently, trained nursing staff would take charge of the parturients and inform the obstetrician. The basic condition of parturients was monitored during the whole process. After that, parturients in each group will be administered vitamin C intravenously except the group for placebo-controlled.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• single-fetus, head position, and full-term vaginal delivery receiving epidural labor analgesia.

Exclusion Criteria:

• have a fever before epidural analgesia, acute infection on admission, incomplete baseline data, fatal fetal malformations or comorbidities, duration from admission to delivery of more than 72 hours or less than 3 hours, or an American Society of Anesthesiologists (ASA) classification of = ?.

Related Conditions & MeSH terms

• Fever
• Obstetric Labor Complications

Intervention

Drug:
• Vitamin C Injection
Drug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia.

Other:
• Normal saline
The placebo comparator will receive normal saline with the same volume and be administered after the induction of epidural labor anesthesia.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kunyue Li	Third Affiliated Hospital of Zhengzhou University

References & Publications (4)

Hensel D, Zhang F, Carter EB, Frolova AI, Odibo AO, Kelly JC, Cahill AG, Raghuraman N. Severity of intrapartum fever and neonatal outcomes. Am J Obstet Gynecol. 2022 Sep;227(3):513.e1-513.e8. doi: 10.1016/j.ajog.2022.05.031. Epub 2022 May 19. — View Citation

Morton S, Kua J, Mullington CJ. Epidural analgesia, intrapartum hyperthermia, and neonatal brain injury: a systematic review and meta-analysis. Br J Anaesth. 2021 Feb;126(2):500-515. doi: 10.1016/j.bja.2020.09.046. Epub 2020 Nov 18. — View Citation

Patel S, Ciechanowicz S, Blumenfeld YJ, Sultan P. Epidural-related maternal fever: incidence, pathophysiology, outcomes, and management. Am J Obstet Gynecol. 2023 May;228(5S):S1283-S1304.e1. doi: 10.1016/j.ajog.2022.06.026. Epub 2023 Mar 14. — View Citation

Sultan P, Segal S. Epidural-Related Maternal Fever: Still a Hot Topic, But What Are the Burning Issues? Anesth Analg. 2020 Feb;130(2):318-320. doi: 10.1213/ANE.0000000000004576. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrapartum fever or not	The temperature of parturients = 37.5?	Every two hours after receiving epidural labor analgesia, until baby delivery
Primary	The temperature of parturients	After receiving epidural labor analgesia	Every two hours after receiving epidural labor analgesia, until baby delivery.
Primary	The duration of intrapartum fever	If parturients develop intrapartum fever, record the lasting time of fever.	Every two hours after receiving epidural labor analgesia, until baby delivery.
Primary	Complete blood count indicators	Record the blood cell indicators for three times totally	Take blood test immediately before analgesia, immediately when parturients is developing intrapartum fever and immediately after delivery
Secondary	Visual analogue scale(VAS)	Record the Visual analogue scale(VAS) of parturients at every time point. The visual analogue scale scores ranged from 0 to 10, with higher scores indicating increased pain levels.	Every two hours after receiving epidural labor analgesia, until baby delivery.
Secondary	Amount of total analgesics	Record the amount of total analgesics	immediately After the baby is delivered
Secondary	Side effects on mothers	Record the incidence of pruritus, vertigo, prosthesis, dyspnea, nausea and vomiting of parturients	immediately After the baby is delivered
Secondary	the duration of total labor	Delivery characteristics 1	immediately After the baby is delivered
Secondary	Incidence of rupture of membranes	Delivery characteristics 1	immediately After the baby is delivered
Secondary	Delivery characteristics 2	Record the incidence of lateral vaginal incision, postpartum hemorrhage, amniotic fluid contamination.	immediately After the baby is delivered
Secondary	Record the weight of the baby.	Infant characteristics 1	immediately After the baby is delivered
Secondary	Record the gender of the baby.	Infant characteristics 2	immediately After the baby is delivered
Secondary	Apgar score	Record the 1min, 5min Apgar score of the baby.	immediately After the baby is delivered
Secondary	the incidence of fetal distress	Infant characteristics 4	immediately After the baby is delivered
Secondary	Record the infant ward administration.	Infant characteristics 4	immediately After the baby is delivered