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

June 30, 2024 updated by: Kunyue Li

Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia : A Randomized Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Third Affiliated Hospital of Zhengzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Vitamin C Injection
Drug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia.
Other Names:
  • Suicheng, H20046552
Experimental: 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.
Drug: Vitamin C Injection
Drug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia.
Other Names:
  • Suicheng, H20046552
Experimental: 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.
Drug: Vitamin C Injection
Drug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia.
Other Names:
  • Suicheng, H20046552
Placebo Comparator: 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.
Other: Normal saline
The placebo comparator will receive normal saline with the same volume and be administered after the induction of epidural labor anesthesia.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intrapartum fever or not
Time Frame: Every two hours after receiving epidural labor analgesia, until baby delivery
The temperature of parturients ≥ 37.5℃
Every two hours after receiving epidural labor analgesia, until baby delivery
The temperature of parturients
Time Frame: Every two hours after receiving epidural labor analgesia, until baby delivery.
After receiving epidural labor analgesia
Every two hours after receiving epidural labor analgesia, until baby delivery.
The duration of intrapartum fever
Time Frame: Every two hours after receiving epidural labor analgesia, until baby delivery.
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
Time Frame: 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
Take blood test immediately before analgesia, immediately when parturients is developing intrapartum fever and immediately after delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual analogue scale(VAS)
Time Frame: 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.
Every two hours after receiving epidural labor analgesia, until baby delivery.
Amount of total analgesics
Time Frame: immediately After the baby is delivered
Record the amount of total analgesics
immediately After the baby is delivered
Side effects on mothers
Time Frame: immediately After the baby is delivered
Record the incidence of pruritus, vertigo, prosthesis, dyspnea, nausea and vomiting of parturients
immediately After the baby is delivered
the duration of total labor
Time Frame: immediately After the baby is delivered
Delivery characteristics 1
immediately After the baby is delivered
Incidence of rupture of membranes
Time Frame: immediately After the baby is delivered
Delivery characteristics 1
immediately After the baby is delivered
Delivery characteristics 2
Time Frame: immediately After the baby is delivered
Record the incidence of lateral vaginal incision, postpartum hemorrhage, amniotic fluid contamination.
immediately After the baby is delivered
Record the weight of the baby.
Time Frame: immediately After the baby is delivered
Infant characteristics 1
immediately After the baby is delivered
Record the gender of the baby.
Time Frame: immediately After the baby is delivered
Infant characteristics 2
immediately After the baby is delivered
Apgar score
Time Frame: immediately After the baby is delivered
Record the 1min, 5min Apgar score of the baby.
immediately After the baby is delivered
the incidence of fetal distress
Time Frame: immediately After the baby is delivered
Infant characteristics 4
immediately After the baby is delivered
Record the infant ward administration.
Time Frame: immediately After the baby is delivered
Infant characteristics 4
immediately After the baby is delivered

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kunyue Li

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Third Affiliated Hospital of Zhengzhou University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tao Wang, PhD, the Third Affilated Hospital of Zhengzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-085-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Start from January, 2026 to April, 2026.

IPD Sharing Access Criteria

At this platform and further send e-mail to investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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