Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Third Affiliated Hospital of Zhengzhou University | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Every two hours after receiving epidural labor analgesia, until baby delivery. |
| Amount of total analgesics |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kunyue Li, M.M | Contact | +8615836298766 | likunyue0312@163.com | |
| Tao Wang, PhD | Contact | +8615836298766 | wanglintao516@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tao Wang, PhD | the Third Affilated Hospital of Zhengzhou University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36925412 | Result | 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. | |
| 31934906 | 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. |
Not provided
Not provided
We will upload our main outcomes, study protocol, and statistical methods on this platform after all the work is done, and further inquiries can be directed to our investigators.
Start from January, 2026 to April, 2026.
At this platform and further send e-mail to investigators.
Not provided
Not provided
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D005334 | Fever |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001832 | Body Temperature Changes |
Not provided
Not provided
| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
|
| Normal saline | Other | The placebo comparator will receive normal saline with the same volume and be administered after the induction of epidural labor anesthesia. |
|
Record the amount of total analgesics |
| immediately After the baby is delivered |
| Side effects on mothers | Record the incidence of pruritus, vertigo, prosthesis, dyspnea, nausea and vomiting of parturients | immediately After the baby is delivered |
| the duration of total labor | Delivery characteristics 1 | immediately After the baby is delivered |
| Incidence of rupture of membranes | Delivery characteristics 1 | immediately After the baby is delivered |
| Delivery characteristics 2 | Record the incidence of lateral vaginal incision, postpartum hemorrhage, amniotic fluid contamination. | immediately After the baby is delivered |
| Record the weight of the baby. | Infant characteristics 1 | immediately After the baby is delivered |
| Record the gender of the baby. | Infant characteristics 2 | immediately After the baby is delivered |
| Apgar score | Record the 1min, 5min Apgar score of the baby. | immediately After the baby is delivered |
| the incidence of fetal distress | Infant characteristics 4 | immediately After the baby is delivered |
| Record the infant ward administration. | Infant characteristics 4 | immediately After the baby is delivered |
| 35598690 | 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. |
| 33218673 | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |