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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstetric Labor Complications; Fever
• Intervention / Treatment: Drug: Vitamin C Injection; Other: Normal saline

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kunyue Li, M.M; Phone Number: +8615836298766; Email: likunyue0312@163.com
• Study Contact Backup: Name: Tao Wang, PhD; Phone Number: +8615836298766; Email: wanglintao516@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 ≥ Ⅲ.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group C1; The vitamin C1 group will receive 1 g of vitamin C intravenously administered after the induction of epidural labor anesthesia. The infusion speed will be set at 5ml/min.	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 Names: Suicheng, H20046552
Experimental: Group C2; The vitamin C2 group will receive 2 g of vitamin C intravenously administered after the induction of epidural labor anesthesia. The infusion speed will be set at 5ml/min.	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 Names: Suicheng, H20046552
Experimental: Group C3; The vitamin C3 group will receive 3 g of vitamin C intravenously administered after the induction of epidural labor anesthesia. The infusion speed will be set at 5ml/min.	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 Names: Suicheng, H20046552
Placebo Comparator: Group P; The control group P will receive normal saline and be administered after the induction of epidural labor anesthesia. The infusion speed will be set at 5ml/min.	Other: Normal saline; The placebo comparator will receive normal saline with the same volume and be administered after the induction of epidural labor anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrapartum fever or not	The temperature of parturients ≥ 37.5℃	Every two hours after receiving epidural labor analgesia, until baby delivery
The temperature of parturients	After receiving epidural labor analgesia	Every two hours after receiving epidural labor analgesia, until baby delivery.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Amount of total analgesics	Record the amount of total analgesics	immediately After the baby is delivered
Side effects on mothers	Record the incidence of pruritus, vertigo, prosthesis, dyspnea, nausea and vomiting of parturients	immediately After the baby is delivered
the duration of total labor	Delivery characteristics 1	immediately After the baby is delivered
Incidence of rupture of membranes	Delivery characteristics 1	immediately After the baby is delivered
Delivery characteristics 2	Record the incidence of lateral vaginal incision, postpartum hemorrhage, amniotic fluid contamination.	immediately After the baby is delivered
Record the weight of the baby.	Infant characteristics 1	immediately After the baby is delivered
Record the gender of the baby.	Infant characteristics 2	immediately After the baby is delivered
Apgar score	Record the 1min, 5min Apgar score of the baby.	immediately After the baby is delivered
the incidence of fetal distress	Infant characteristics 4	immediately After the baby is delivered
Record the infant ward administration.	Infant characteristics 4	immediately After the baby is delivered

Collaborators and Investigators

• Sponsor: Kunyue Li
• Collaborators: Third Affiliated Hospital of Zhengzhou University
• Investigators: Study Director: Tao Wang, PhD, the Third Affilated Hospital of Zhengzhou University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; Epidural analgesia; Vitamin C; Intrapartum maternal fever
• Additional Relevant MeSH Terms: Pregnancy Complications; Body Temperature Changes; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Fever
• Other Study ID Numbers: 2024-085-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will upload our main outcomes, study protocol, and statistical methods on this platform after all the work is done, and further inquiries can be directed to our investigators.
• IPD Sharing Time Frame: Start from January, 2026 to April, 2026.
• IPD Sharing Access Criteria: At this platform and further send e-mail to investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No