Obstetric Labor ComplicationsPhase 4EIVCIMFAELANCT06354582
Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia
A Phase 4 study testing Vitamin C Injection and Normal saline in people with Obstetric Labor Complications and Fever, run by Kunyue Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Labor Complications, Fever
- What is being tested?
- Vitamin C Injection and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- single-fetus, head position, and full-term vaginal delivery receiving epidural labor analgesia.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Kunyue Li, 15836298766, likunyue0312@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstetric Labor Complications, Fever
- Being tested
- Vitamin C Injection, Normal saline
- Keywords
- Intrapartum maternal fever, Epidural analgesia, Inflammation, Vitamin C
- Medical subject headings
- Obstetric Labor Complications, Fever, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C InjectionDrug
Also called Suicheng, H20046552
Drug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia.
Normal salineOther
The placebo comparator will receive normal saline with the same volume and be administered after the induction of epidural labor anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vitamin C Injection |
| 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. Receives: Drug: Vitamin C Injection |
| 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. Receives: Drug: Vitamin C Injection |
| 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. Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrapartum fever or not
The temperature of parturients ≥ 37.5℃
Measured: Every two hours after receiving epidural labor analgesia, until baby delivery
The temperature of parturients
After receiving epidural labor analgesia
Measured: 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.
Measured: Every two hours after receiving epidural labor analgesia, until baby delivery.
Complete blood count indicators
Record the blood cell indicators for three times totally
Measured: Take blood test immediately before analgesia, immediately when parturients is developing intrapartum fever and immediately after delivery
Secondary outcomes (11)
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.
Measured: Every two hours after receiving epidural labor analgesia, until baby delivery.
Amount of total analgesics
Record the amount of total analgesics
Measured: immediately After the baby is delivered
Side effects on mothers
Record the incidence of pruritus, vertigo, prosthesis, dyspnea, nausea and vomiting of parturients
Measured: immediately After the baby is delivered
the duration of total labor
Delivery characteristics 1
Measured: immediately After the baby is delivered
Incidence of rupture of membranes
Delivery characteristics 1
Measured: immediately After the baby is delivered
Delivery characteristics 2
Record the incidence of lateral vaginal incision, postpartum hemorrhage, amniotic fluid contamination.
Measured: immediately After the baby is delivered
Record the weight of the baby.
Infant characteristics 1
Measured: immediately After the baby is delivered
Record the gender of the baby.
Infant characteristics 2
Measured: immediately After the baby is delivered
Apgar score
Record the 1min, 5min Apgar score of the baby.
Measured: immediately After the baby is delivered
the incidence of fetal distress
Infant characteristics 4
Measured: immediately After the baby is delivered
Record the infant ward administration.
Infant characteristics 4
Measured: immediately After the baby is delivered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start15 Apr 2024
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstetric Labor ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunyue Li
- Sponsor type
- University, hospital or other
- Collaborators
- Third Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor-investigator, Kunyue Li, Third Affiliated Hospital of Zhengzhou University
- Investigators
- Tao Wang, PhD, Study director, the Third Affilated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354582
- Sponsor's protocol ID
- 2024-085-01
- Acronym
- EIVCIMFAELA
- Status last verified
- Jun 2024
- First submitted
- 26 Mar 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36925412Sultan 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.
PubMed 31934906Hensel 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.
PubMed 35598690Morton 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.
PubMed 33218673
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06354582
- Acronym / sponsor ID
- EIVCIMFAELA / 2024-085-01
- Conditions
- Obstetric Labor Complications, Fever
- Keywords
- Intrapartum maternal fever, Epidural analgesia, Inflammation, Vitamin C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kunyue LiUniversity, hospital or other
- Collaborators
- Third Affiliated Hospital of Zhengzhou University
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group C1 | Experimental | Drug: Vitamin C InjectionThe 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 | Drug: Vitamin C InjectionThe 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 | Drug: Vitamin C InjectionThe 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 | Other: Normal salineThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- single-fetus, head position, and full-term vaginal delivery receiving epidural labor analgesia.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C InjectionAlso: Suicheng, H20046552Drug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia. | Drug | Group C1, Group C2, Group C3 |
| Normal salineThe placebo comparator will receive normal saline with the same volume and be administered after the induction of epidural labor anesthesia. | Other | Group P |
Primary outcome
Intrapartum fever or not
Time frame: Every two hours after receiving epidural labor analgesia, until baby delivery
The temperature of parturients ≥ 37.5℃
The temperature of parturients
Time frame: Every two hours after receiving epidural labor analgesia, until baby delivery.
After receiving epidural labor analgesia
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.
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
11 secondary outcomes
Visual analogue scale(VAS)
Time frame: Every two hours after receiving epidural labor analgesia, until baby delivery.
Amount of total analgesics
Time frame: immediately After the baby is delivered
Side effects on mothers
Time frame: immediately After the baby is delivered
the duration of total labor
Time frame: immediately After the baby is delivered
Incidence of rupture of membranes
Time frame: immediately After the baby is delivered
Delivery characteristics 2
Time frame: immediately After the baby is delivered
Record the weight of the baby.
Time frame: immediately After the baby is delivered
Record the gender of the baby.
Time frame: immediately After the baby is delivered
Apgar score
Time frame: immediately After the baby is delivered
the incidence of fetal distress
Time frame: immediately After the baby is delivered
Record the infant ward administration.
Time frame: immediately After the baby is delivered
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Results publication: PubMed 36925412Patel 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.
- Results publication: PubMed 31934906Sultan 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.
- Results publication: PubMed 35598690Hensel 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.
- Results publication: PubMed 33218673Morton 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Wang, PhD study director
the Third Affilated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin C Injection and Normal saline in people with Obstetric Labor Complications and Fever, run by Kunyue Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kunyue Li, M.M (+8615836298766, likunyue0312@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrapartum fever or not (time frame: Every two hours after receiving epidural labor analgesia, until baby delivery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06354582, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.