search
Back to results

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

Primary Purpose

Labor Pain, Pain, Neurologic Manifestations

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Epidural analgesia
Combined spinal-epidural analgesia
Continuous epidural infusion
Intermittent epidural bolus
Sponsored by
ShanWu Feng, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Fever, Patient controlled epidural analgesia, Labor analgesia, Epidural analgesia, Combined spinal-epidural analgesia

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

5

6

7

8

Arm Description

Epidural analgesia (EA) with continuous epidural infusion(CEI)

Combined spinal-epidural analgesia (CSEA) with continuous epidural infusion(CEI)

Epidural analgesia (EA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)

Epidural analgesia (EA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)

Epidural analgesia (EA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)

Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)

Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)

Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)

Outcomes

Primary Outcome Measures

Maternal oral and tympanic temperature

Secondary Outcome Measures

Maternal serum Interleukin-1β
Cord serum Interleukin-1β
Maternal serum Interleukin-6
Cord serum Interleukin-6
Maternal serum Interleukin-10
Cord serum Interleukin-10
Maternal serum tumor necrosis factor-α
Cord serum tumor necrosis factor-α
Regression and correlation analyses between maternal and cord serum cytokines
Placental routine pathologic examination
Maternal and cord blood gase analysis
Maternal modified Bromage scale and visual analogue scale
Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture
Rates of cesarean delivery and instrument-assisted delivery
Indications of cesarean delivery
Duration of analgesia
Durations of labor stages
Maternal satisfaction with analgesia
Use of oxytocin after analgesia
Low back pain at 3 months after vaginal delivery
Breastfeeding success at 6 weeks after vaginal delivery
Neonatal Apgar scale
Incidence of maternal side effects
Neonatal Neurologic and Adaptive Capacity Score
Maximal oxytocin dose
Neonatal sepsis evaluation
Neonatal antibiotic treatment
Maternal heart rate, respiratory rate, and blood pressure
Highest thoracic sensory level to alcohol
Uterine contraction
Neonatal rectal temperature
Fetal heart rate
Maternal group B streptococcus (GBS) colonization
Number of vaginal examinations, duration from rupture of the membranes to delivery, mode of membranes ruptured
Neonatal weight
Uterine artery, umbilical artery and vein, fetus middle cerebral artery by ultrasound
Maternal serum epinephrine, norepinephrine, insulin, glucagon, corticotropin releasing hormone, adrenocorticotropic hormone, cortisol, blood glucose, oxytocin, prostaglandin E2 and prostaglandin F2 alpha
Maternal postpartum depression

Full Information

First Posted
October 7, 2012
Last Updated
January 14, 2015
Sponsor
ShanWu Feng, M.D.
search

1. Study Identification

Unique Protocol Identification Number
NCT01708668
Brief Title
The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia
Acronym
EIEBFLA
Official Title
The Effects of Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Fever for Labor Analgesia in Primiparous Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ShanWu Feng, M.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Pain, Neurologic Manifestations, Signs and Symptoms, Pathological Conditions, Signs and Symptoms
Keywords
Fever, Patient controlled epidural analgesia, Labor analgesia, Epidural analgesia, Combined spinal-epidural analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Epidural analgesia (EA) with continuous epidural infusion(CEI)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Combined spinal-epidural analgesia (CSEA) with continuous epidural infusion(CEI)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Epidural analgesia (EA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)
Arm Title
4
Arm Type
Active Comparator
Arm Description
Epidural analgesia (EA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)
Arm Title
5
Arm Type
Active Comparator
Arm Description
Epidural analgesia (EA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)
Arm Title
6
Arm Type
Active Comparator
Arm Description
Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)
Arm Title
7
Arm Type
Active Comparator
Arm Description
Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)
Arm Title
8
Arm Type
Active Comparator
Arm Description
Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)
Intervention Type
Procedure
Intervention Name(s)
Epidural analgesia
Intervention Type
Procedure
Intervention Name(s)
Combined spinal-epidural analgesia
Intervention Type
Procedure
Intervention Name(s)
Continuous epidural infusion
Intervention Type
Procedure
Intervention Name(s)
Intermittent epidural bolus
Primary Outcome Measure Information:
Title
Maternal oral and tympanic temperature
Time Frame
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Secondary Outcome Measure Information:
Title
Maternal serum Interleukin-1β
Time Frame
At time of placental delivery and 3, 6 and 12 hours later
Title
Cord serum Interleukin-1β
Time Frame
At time of placental delivery
Title
Maternal serum Interleukin-6
Time Frame
At time of placental delivery and 3, 6 and 12 hours later
Title
Cord serum Interleukin-6
Time Frame
At time of placental delivery
Title
Maternal serum Interleukin-10
Time Frame
At time of placental delivery and 3, 6 and 12 hours later
Title
Cord serum Interleukin-10
Time Frame
At time of placental delivery
Title
Maternal serum tumor necrosis factor-α
Time Frame
At time of placental delivery and 3, 6 and 12 hours later
Title
Cord serum tumor necrosis factor-α
Time Frame
At time of placental delivery
Title
Regression and correlation analyses between maternal and cord serum cytokines
Time Frame
At twelve hours postpartum
Title
Placental routine pathologic examination
Time Frame
At time of placental delivery
Title
Maternal and cord blood gase analysis
Time Frame
At time of placental delivery
Title
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)
Title
Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture
Time Frame
At two hours postpartum
Title
Rates of cesarean delivery and instrument-assisted delivery
Time Frame
At time of placental delivery
Title
Indications of cesarean delivery
Time Frame
Initiation of analgesia to placental delivery (approximately 8 hours)
Title
Duration of analgesia
Time Frame
Initiation of analgesia to 2 h postpartum (approximately 10 hours)
Title
Durations of labor stages
Time Frame
From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)
Title
Maternal satisfaction with analgesia
Time Frame
At two hours postpartum
Title
Use of oxytocin after analgesia
Time Frame
At twenty-four hours postpartum
Title
Low back pain at 3 months after vaginal delivery
Time Frame
At the third month after vaginal delivery
Title
Breastfeeding success at 6 weeks after vaginal delivery
Time Frame
At the sixth week after successful delivery
Title
Neonatal Apgar scale
Time Frame
At the first and fifth minutes after baby was born
Title
Incidence of maternal side effects
Time Frame
Initiation of analgesia to 2 hour postpartum (approximately 10 hours)
Title
Neonatal Neurologic and Adaptive Capacity Score
Time Frame
At 30 min, 2 h, and 24 h after baby was born
Title
Maximal oxytocin dose
Time Frame
At twenty-four hours postpartum
Title
Neonatal sepsis evaluation
Time Frame
At 30 min after baby was born
Title
Neonatal antibiotic treatment
Time Frame
One week after baby was born
Title
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)
Title
Highest thoracic sensory level to alcohol
Time Frame
At three hours after initiation of analgesia
Title
Uterine contraction
Time Frame
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Title
Neonatal rectal temperature
Time Frame
At delivery, 30 min after delivery, and 1 h after delivery
Title
Fetal heart rate
Time Frame
From initiation of analgesia to delivery (approximately 8 hours)
Title
Maternal group B streptococcus (GBS) colonization
Time Frame
At time of initiation of analgesia
Title
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)
Title
Neonatal weight
Time Frame
At delivery
Title
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)
Title
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)
Title
Maternal postpartum depression
Time Frame
At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shanwu Feng, M.D.
Phone
+86 25 52226112
Email
shanwufeng@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shanwu Feng, M.D.
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanwu Feng, M.D.
Phone
+86 25 52226112
Email
shanwufeng@163.com
First Name & Middle Initial & Last Name & Degree
Shanwu Feng, M.D.

12. IPD Sharing Statement

Learn more about this trial

The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia

We'll reach out to this number within 24 hrs