Fever, Obstetric Labor Complications
Conditions
Keywords
Intrapartum maternal fever, Epidural analgesia, Inflammation, Vitamin C
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.
Interventions
Drug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia.
OTHERNormal saline
The placebo comparator will receive normal saline with the same volume and be administered after the induction of epidural labor anesthesia.
Sponsors
Third Affiliated Hospital of Zhengzhou University
Kunyue Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of rupture of membranes | immediately After the baby is delivered | Delivery characteristics 1 |
| 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 |
| 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. |
| Apgar score | immediately After the baby is delivered | Record the 1min, 5min Apgar score of the baby. |
| 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 |
| Record the gender of the baby. | immediately After the baby is delivered | Infant characteristics 2 |
| Amount of total analgesics | immediately After the baby is delivered | Record the amount of total analgesics |
| Side effects on mothers | immediately After the baby is delivered | Record the incidence of pruritus, vertigo, prosthesis, dyspnea, nausea and vomiting of parturients |
| the duration of total labor | immediately After the baby is delivered | Delivery characteristics 1 |
Countries
China
Contacts
Primary ContactKunyue Li, M.M
Backup ContactTao Wang, PhD
Outcome results
None listed