MedDataX Logo

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

NCT ID: NCT06354582

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2024-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Epidural Analgesia and Maternal Fever During Labor

NCT04940091

Epidural Analgesia Analgesic Effect Fever
COMPLETED

The Impact of Local Anesthetic Solution Temperature on Epidural-related Maternal Fever

NCT06682416

Epidural Related Maternal Fever Analgesia, Epidural Fever +1 more
RECRUITING NA

A Clinical Study on the Effect of Labor Analgesia on the Postpartum Recovery Outcome of Chinese Parturients

NCT05666024

Analgesia Labor Analgesia
UNKNOWN

Cesarean Rate in Parturients Without Neuraxial Analgesia

NCT01157325

Labor
COMPLETED NA

Evaluation of Fever Occurring in Labor in Patients Receiving Epidural Anesthesia

NCT00326521

Fever
UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstetric Labor Complications Fever

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group C1

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 Type EXPERIMENTAL

Vitamin C Injection

Intervention Type DRUG

Drug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia.

Group C2

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 Type EXPERIMENTAL

Vitamin C Injection

Intervention Type DRUG

Drug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia.

Group C3

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 Type EXPERIMENTAL

Vitamin C Injection

Intervention Type DRUG

Drug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia.

Group P

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.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type OTHER

The placebo comparator will receive normal saline with the same volume and be administered after the induction of epidural labor anesthesia.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin C Injection

Drug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia.

Intervention Type DRUG

Normal saline

The placebo comparator will receive normal saline with the same volume and be administered after the induction of epidural labor anesthesia.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Suicheng, H20046552

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Third Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Kunyue Li

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kunyue Li

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tao Wang, PhD

Role: STUDY_DIRECTOR

the Third Affilated Hospital of Zhengzhou University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kunyue Li, M.M

Role: CONTACT

[email protected]
+8615836298766

Tao Wang, PhD

Role: CONTACT

[email protected]
+8615836298766

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kunyue Li

Role: primary

[email protected]
15836298766

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 36925412 (View on PubMed)

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.

Reference Type RESULT
PMID: 31934906 (View on PubMed)

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.

Reference Type RESULT
PMID: 35598690 (View on PubMed)

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.

Reference Type RESULT
PMID: 33218673 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-085-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Does Maternal Fever During Labor Analgesia Has Any Relationship With Maternal Ventilation?
NCT02339389 COMPLETED
Ten-year Practice of Labor Pain Control in China
NCT00776581 COMPLETED
Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery
NCT02354833 COMPLETED PHASE4
The Comparison Of Nerve Blocks In Cesarean Delivery
NCT03333902 COMPLETED NA
Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery.
NCT06017076 COMPLETED NA
Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery
NCT04991662 COMPLETED PHASE4
Effects of Dextrose Versus Saline Infusion on Intrathecal Morphine-Induced Postoperative Nausea and Vomiting During Gynecological Abdominal Surgeries: Randomized Controlled Double-blind Study
NCT06726980 NOT_YET_RECRUITING PHASE4
Epidural Analgesia in Different Cervix Diameter and the Rate of Cesarean Delivery
NCT00677274 COMPLETED NA
Effect of Lidocaine Infusion on Neuraxial Opioid-induced Pruritus After Cesarean Section
NCT06225323 COMPLETED NA
Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study
NCT06285396 SUSPENDED NA
A Comparison of Different Concentration Ropivacaine for Patient-controlled Epidural Analgesia
NCT03195309 UNKNOWN PHASE1/PHASE2
Preoperative Epidural Labor Analgesia and Postoperative Pain
NCT03381690 COMPLETED
Preload Optimization Guided by Inferior Vena Cava Collapsibility Index
NCT04272580 COMPLETED NA
To Study the Association Among Labor Pain and Physical Parameters in Laboring Pregnant Women
NCT04461704 COMPLETED
Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery
NCT02487303 COMPLETED NA
Sterile Water Injections For Pain Relief İn Labor
NCT02697994 COMPLETED NA
Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia
NCT03507387 COMPLETED NA
Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia
NCT00815022 COMPLETED NA
Does a Single Intravenous Dose of Ketamine Reduce the Need for Supplemental Opioids in Post-Cesarean Section Patients?
NCT00486902 COMPLETED NA
Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section
NCT00432991 COMPLETED PHASE2
Amino Acid Infusion in Mothers Before and During Cesarean Delivery
NCT02575170 COMPLETED NA
Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses in Patients With Severe Preeclampsia
NCT05035485 COMPLETED NA
Perioperative Warming Measures in Cesarean Delivery
NCT05015582 UNKNOWN NA
Effect of Dexmedetomidine on Parturient Undergoing Elective Cesarean Section.
NCT03805945 COMPLETED PHASE4
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia.
NCT04556370 COMPLETED NA