Clinical trial NCT06354582: Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia
Official title: Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obstetric Labor Complications
Fever
Keywords: Intrapartum maternal fever
Epidural analgesia
Inflammation
Vitamin C
Lead sponsor: Third Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Third Affiliated Hospital of Zhengzhou University
First posted: 2024-04-09
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intrapartum fever or not
timeFrame: Every two hours after receiving epidural labor analgesia, until baby delivery
measure: The temperature of parturients
timeFrame: Every two hours after receiving epidural labor analgesia, until baby delivery.
measure: The duration of intrapartum fever
timeFrame: Every two hours after receiving epidural labor analgesia, until baby delivery.
measure: Complete blood count indicators
timeFrame: Take blood test immediately before analgesia, immediately when parturients is developing intrapartum fever and immediately after delivery
Secondary outcomes:
measure: Visual analogue scale(VAS)
timeFrame: Every two hours after receiving epidural labor analgesia, until baby delivery.
measure: Amount of total analgesics
timeFrame: immediately After the baby is delivered
measure: Side effects on mothers
timeFrame: immediately After the baby is delivered
measure: the duration of total labor
timeFrame: immediately After the baby is delivered
measure: Incidence of rupture of membranes
timeFrame: immediately After the baby is delivered
measure: Delivery characteristics 2
timeFrame: immediately After the baby is delivered
measure: Record the weight of the baby.
timeFrame: immediately After the baby is delivered
measure: Record the gender of the baby.
timeFrame: immediately After the baby is delivered
measure: Apgar score
timeFrame: immediately After the baby is delivered
measure: the incidence of fetal distress
timeFrame: immediately After the baby is delivered
measure: Record the infant ward administration.
timeFrame: immediately After the baby is delivered
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Third Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: the Third Affilated Hospital of Zhengzhou University
name: Tao Wang, PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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.