Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorKunyue Li
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
single-fetus, head position, and full-term vaginal delivery receiving epidural labor analgesia.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Vitamin C Injection
DrugDrug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia.
Normal saline
Other interventionThe placebo comparator will receive normal saline with the same volume and be administered after the induction of epidural labor anesthesia.
Treatment groups
400 Participants
are divided into 4 treatment groupsGroup A: Group C1Experimental treatment 1 intervention
Group B: Group C2Experimental treatment 1 intervention
Group C: Group C3Experimental treatment 1 intervention
Group D: Group PPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intrapartum fever or not
The temperature of parturients ≥ 37.5℃
Time frame
Every two hours after receiving epidural labor analgesia, until baby delivery2
The temperature of parturients
After receiving epidural labor analgesia
Time frame
Every two hours after receiving epidural labor analgesia, until baby delivery.3
The duration of intrapartum fever
If parturients develop intrapartum fever, record the lasting time of fever.
Time frame
Every two hours after receiving epidural labor analgesia, until baby delivery.4
Complete blood count indicators
Record the blood cell indicators for three times totally
Time frame
Take blood test immediately before analgesia, immediately when parturients is developing intrapartum fever and immediately after deliverySecondary outcomes
1
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.
Time frame
Every two hours after receiving epidural labor analgesia, until baby delivery.2
Amount of total analgesics
Record the amount of total analgesics
Time frame
immediately After the baby is delivered3
Side effects on mothers
Record the incidence of pruritus, vertigo, prosthesis, dyspnea, nausea and vomiting of parturients
Time frame
immediately After the baby is delivered4
the duration of total labor
Delivery characteristics 1
Time frame
immediately After the baby is deliveredSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kunyue Li
Lead sponsor
Third Affiliated Hospital of Zhengzhou University
Sponsor institution
Third Affiliated Hospital of Zhengzhou University
Collaborator
Source ClinicalTrials.gov