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

NCT06354582 | Recruiting Phase 4 DMC

• 1 other identifier: 2024-085-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstetric Labor Complications; Fever

Keywords

Intrapartum maternal fever; Epidural analgesia; Inflammation; Vitamin C

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• Visual analogue scale(VAS)

  Every two hours after receiving epidural labor analgesia, until baby delivery.

• Amount of total analgesics

  immediately After the baby is delivered

• Side effects on mothers

  immediately After the baby is delivered

• the duration of total labor

  immediately After the baby is delivered

• Incidence of rupture of membranes

  immediately After the baby is delivered

Study Arms (4)

Group C1

EXPERIMENTAL

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

Group C2

EXPERIMENTAL

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

Group C3

EXPERIMENTAL

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

Group P

PLACEBO COMPARATOR

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

Interventions

Vitamin C Injection DRUG

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

Also known as: Suicheng, H20046552

Group C1; Group C2; Group C3

Normal saline OTHER

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

Group P

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kunyue Li: lead
• Third Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 36925412 RESULT

• 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.

  PMID: 31934906 RESULT

• 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.

  PMID: 35598690 RESULT

• 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.

  PMID: 33218673 RESULT

MeSH Terms

Conditions

Obstetric Labor Complications; Fever; Inflammation

Interventions

Ascorbic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Tao Wang, PhD

  the Third Affilated Hospital of Zhengzhou University

  STUDY DIRECTOR

Central Study Contacts

Kunyue Li, M.M

CONTACT

+8615836298766; likunyue0312@163.com

Tao Wang, PhD

CONTACT

+8615836298766; wanglintao516@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parturients are randomly assigned to either vitamin C(1,2,3) or control. The vitamin C group received 1 g, 2g, and 3g of vitamin C intravenously respectively and the control group received normal saline, administered after the induction of epidural labor anesthesia. There will be 100 cases in each group. The infusion speed will be set at 5ml/min.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 9, 2024
• Study Start: April 15, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start from January, 2026 to April, 2026.
• Access Criteria: At this platform and further send e-mail to investigators.

Locations

CN (1)