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

Phase 4

Recruiting

• Conditions: Obstetric Labor Complications; Fever
• Interventions: Drug: Vitamin C Injection; Other: Normal saline

• Registration Number: NCT06354582
• Lead Sponsor: Kunyue Li

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.

Study Timeline

• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-09
• Study Start: 2024-04-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-30
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C1	Vitamin C Injection	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.
Group C2	Vitamin C Injection	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.
Group C3	Vitamin C Injection	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.
Group P	Normal saline	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.

Primary Outcome Measures

Name	Time	Method
Complete blood count indicators	Take blood test immediately before analgesia, immediately when parturients is developing intrapartum fever and immediately after delivery	Record the blood cell indicators for three times totally
Intrapartum fever or not	Every two hours after receiving epidural labor analgesia, until baby delivery	The temperature of parturients ≥ 37.5℃
The temperature of parturients	Every two hours after receiving epidural labor analgesia, until baby delivery.	After receiving epidural labor analgesia
The duration of intrapartum fever	Every two hours after receiving epidural labor analgesia, until baby delivery.	If parturients develop intrapartum fever, record the lasting time of fever.

Secondary Outcome Measures

Name	Time	Method
the incidence of fetal distress	immediately After the baby is delivered	Infant characteristics 4
Record the infant ward administration.	immediately After the baby is delivered	Infant characteristics 4
Amount of total analgesics	immediately After the baby is delivered	Record the amount of total analgesics
Incidence of rupture of membranes	immediately After the baby is delivered	Delivery characteristics 1
Visual analogue scale(VAS)	Every two hours after receiving epidural labor analgesia, until baby delivery.	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.
Side effects on mothers	immediately After the baby is delivered	Record the incidence of pruritus, vertigo, prosthesis, dyspnea, nausea and vomiting of parturients
Delivery characteristics 2	immediately After the baby is delivered	Record the incidence of lateral vaginal incision, postpartum hemorrhage, amniotic fluid contamination.
Record the weight of the baby.	immediately After the baby is delivered	Infant characteristics 1
Record the gender of the baby.	immediately After the baby is delivered	Infant characteristics 2
Apgar score	immediately After the baby is delivered	Record the 1min, 5min Apgar score of the baby.
the duration of total labor	immediately After the baby is delivered	Delivery characteristics 1

Trial Locations

Locations (1)

Third Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China