The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia (EIEBFLA)

January 14, 2015 updated by: ShanWu Feng, M.D.

The Effects of Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Fever for Labor Analgesia in Primiparous Women

Epidural analgesia is associated with maternal intra-partum fever during labor. Intermittent epidural injections appear to reduce the incidence of maternal intra-partum fever compared to continuous epidural infusion during labor analgesia. However, the optimal combination of bolus volume and administrating interval has not yet been compared. The purpose of this prospective, randomized, double-blind trial was to determine how intermittent epidural bolus reduced the incidence of maternal intra-partum fever compared with continuous epidural infusion during labor.

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
12000

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.
  • Not Applicable

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 Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Recruiting
        • Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University
        • Contact:
        • Principal Investigator:
          • Shanwu Feng, M.D.

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

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Nulliparous women
  • Required labor analgesia
  • Chinese
  • Spontaneous labor

Exclusion Criteria:

  • Contraindications for epidural analgesia
  • Allergic to opioids and/or local anesthetics
  • Failed to performing epidural catheterization
  • Organic dysfunction
  • Those who were not willing to or could not finish the whole study at any time
  • Using or used in the past 14 days of the monoamine oxidase inhibitors
  • Alcohol addictive or narcotic dependent patients
  • Subjects with a nonvertex presentation or scheduled induction of labor
  • Twin gestation and breech presentation

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: Treatment
  • 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.
Active Comparator: 1
Epidural analgesia (EA) with continuous epidural infusion(CEI)
Procedure: Epidural analgesia
Procedure: Continuous epidural infusion
Active Comparator: 2
Combined spinal-epidural analgesia (CSEA) with continuous epidural infusion(CEI)
Procedure: Continuous epidural infusion
Procedure: Combined spinal-epidural analgesia
Active Comparator: 3
Epidural analgesia (EA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)
Procedure: Epidural analgesia
Procedure: Intermittent epidural bolus
Active Comparator: 4
Epidural analgesia (EA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)
Procedure: Epidural analgesia
Procedure: Intermittent epidural bolus
Active Comparator: 5
Epidural analgesia (EA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)
Procedure: Epidural analgesia
Procedure: Intermittent epidural bolus
Active Comparator: 6
Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)
Procedure: Intermittent epidural bolus
Procedure: Combined spinal-epidural analgesia
Active Comparator: 7
Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)
Procedure: Intermittent epidural bolus
Procedure: Combined spinal-epidural analgesia
Active Comparator: 8
Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)
Procedure: Intermittent epidural bolus
Procedure: Combined spinal-epidural analgesia

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
Time Frame
Maternal oral and tympanic temperature
Time Frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)

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
Time Frame
Rates of cesarean delivery and instrument-assisted delivery
Time Frame: At time of placental delivery
At time of placental delivery
Duration of analgesia
Time Frame: Initiation of analgesia to 2 h postpartum (approximately 10 hours)
Initiation of analgesia to 2 h postpartum (approximately 10 hours)
Durations of labor stages
Time Frame: From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)
From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)
Use of oxytocin after analgesia
Time Frame: At twenty-four hours postpartum
At twenty-four hours postpartum
Incidence of maternal side effects
Time Frame: Initiation of analgesia to 2 hour postpartum (approximately 10 hours)
Initiation of analgesia to 2 hour postpartum (approximately 10 hours)
Neonatal Apgar scale
Time Frame: At the first and fifth minutes after baby was born
At the first and fifth minutes after baby was born
Fetal heart rate
Time Frame: From initiation of analgesia to delivery (approximately 8 hours)
From initiation of analgesia to delivery (approximately 8 hours)
Neonatal weight
Time Frame: At delivery
At delivery
Breastfeeding success at 6 weeks after vaginal delivery
Time Frame: At the sixth week after successful delivery
At the sixth week after successful delivery
Maternal serum Interleukin-1β
Time Frame: At time of placental delivery and 3, 6 and 12 hours later
At time of placental delivery and 3, 6 and 12 hours later
Cord serum Interleukin-1β
Time Frame: At time of placental delivery
At time of placental delivery
Maternal serum Interleukin-6
Time Frame: At time of placental delivery and 3, 6 and 12 hours later
At time of placental delivery and 3, 6 and 12 hours later
Cord serum Interleukin-6
Time Frame: At time of placental delivery
At time of placental delivery
Maternal serum Interleukin-10
Time Frame: At time of placental delivery and 3, 6 and 12 hours later
At time of placental delivery and 3, 6 and 12 hours later
Cord serum Interleukin-10
Time Frame: At time of placental delivery
At time of placental delivery
Maternal serum tumor necrosis factor-α
Time Frame: At time of placental delivery and 3, 6 and 12 hours later
At time of placental delivery and 3, 6 and 12 hours later
Cord serum tumor necrosis factor-α
Time Frame: At time of placental delivery
At time of placental delivery
Regression and correlation analyses between maternal and cord serum cytokines
Time Frame: At twelve hours postpartum
At twelve hours postpartum
Placental routine pathologic examination
Time Frame: At time of placental delivery
At time of placental delivery
Maternal and cord blood gase analysis
Time Frame: At time of placental delivery
At time of placental delivery
Maternal modified Bromage scale and visual analogue scale
Time Frame: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture
Time Frame: At two hours postpartum
At two hours postpartum
Indications of cesarean delivery
Time Frame: Initiation of analgesia to placental delivery (approximately 8 hours)
Initiation of analgesia to placental delivery (approximately 8 hours)
Maternal satisfaction with analgesia
Time Frame: At two hours postpartum
At two hours postpartum
Low back pain at 3 months after vaginal delivery
Time Frame: At the third month after vaginal delivery
At the third month after vaginal delivery
Neonatal Neurologic and Adaptive Capacity Score
Time Frame: At 30 min, 2 h, and 24 h after baby was born
At 30 min, 2 h, and 24 h after baby was born
Maximal oxytocin dose
Time Frame: At twenty-four hours postpartum
At twenty-four hours postpartum
Neonatal sepsis evaluation
Time Frame: At 30 min after baby was born
At 30 min after baby was born
Neonatal antibiotic treatment
Time Frame: One week after baby was born
One week after baby was born
Maternal heart rate, respiratory rate, and blood pressure
Time Frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Highest thoracic sensory level to alcohol
Time Frame: At three hours after initiation of analgesia
At three hours after initiation of analgesia
Uterine contraction
Time Frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Neonatal rectal temperature
Time Frame: At delivery, 30 min after delivery, and 1 h after delivery
At delivery, 30 min after delivery, and 1 h after delivery
Maternal group B streptococcus (GBS) colonization
Time Frame: At time of initiation of analgesia
At time of initiation of analgesia
Number of vaginal examinations, duration from rupture of the membranes to delivery, mode of membranes ruptured
Time Frame: From initiation of analgesia to delivery (approximately 8 hours)
From initiation of analgesia to delivery (approximately 8 hours)
Uterine artery, umbilical artery and vein, fetus middle cerebral artery by ultrasound
Time Frame: At time of initiation of analgesia and hourly thereafter until delivery (approximately 8 hours)
At time of initiation of analgesia and hourly thereafter until delivery (approximately 8 hours)
Maternal serum epinephrine, norepinephrine, insulin, glucagon, corticotropin releasing hormone, adrenocorticotropic hormone, cortisol, blood glucose, oxytocin, prostaglandin E2 and prostaglandin F2 alpha
Time Frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Maternal postpartum depression
Time Frame: At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year)
At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year)

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.
ShanWu Feng, M.D.

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: Shanwu Feng, M.D., Nanjing Medical University

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

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.
October 1, 2012

Primary Completion (Anticipated)

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.
July 1, 2015

Study Completion (Anticipated)

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.
June 1, 2017

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).
October 7, 2012

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.
October 15, 2012

First Posted (Estimate)

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.
October 17, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
January 15, 2015

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.
January 14, 2015

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.
January 1, 2015

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.
  • NJMCHH-2012-A010
  • 08NMUM063 (Other Grant/Funding Number: Nanjing Medical University)
  • YKK08119 (Other Grant/Funding Number: Nanjing Department of Health)
  • YKK11058 (Other Grant/Funding Number: Nanjing Department of Health)

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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