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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
ShanWu Feng, M.D., Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01708668
First received: October 7, 2012
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Signs and Symptoms
Procedure: Epidural analgesia
Procedure: Combined spinal-epidural analgesia
Procedure: Continuous epidural infusion
Procedure: Intermittent epidural bolus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Fever for Labor Analgesia in Primiparous Women

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Maternal oral temperature [ Time Frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maternal serum Interleukin-1β [ Time Frame: At time of placental delivery and 3, 6 and 12 hours later ] [ Designated as safety issue: No ]
  • Cord serum Interleukin-1β [ Time Frame: At time of placental delivery ] [ Designated as safety issue: No ]
  • Maternal serum Interleukin-6 [ Time Frame: At time of placental delivery and 3, 6 and 12 hours later ] [ Designated as safety issue: No ]
  • Cord serum Interleukin-6 [ Time Frame: At time of placental delivery ] [ Designated as safety issue: No ]
  • Maternal serum Interleukin-10 [ Time Frame: At time of placental delivery and 3, 6 and 12 hours later ] [ Designated as safety issue: No ]
  • Cord serum Interleukin-10 [ Time Frame: At time of placental delivery ] [ Designated as safety issue: No ]
  • Maternal serum tumor necrosis factor-α [ Time Frame: At time of placental delivery and 3, 6 and 12 hours later ] [ Designated as safety issue: No ]
  • Cord serum tumor necrosis factor-α [ Time Frame: At time of placental delivery ] [ Designated as safety issue: No ]
  • Regression and correlation analyses between maternal and cord serum cytokines [ Time Frame: At twelve hours postpartum ] [ Designated as safety issue: No ]
  • Placental routine pathologic examination [ Time Frame: At time of placental delivery ] [ Designated as safety issue: No ]
  • Maternal and cord blood gase analysis [ Time Frame: At time of placental delivery ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture [ Time Frame: At two hours postpartum ] [ Designated as safety issue: No ]
  • Rates of cesarean delivery and instrument-assisted delivery [ Time Frame: At time of placental delivery ] [ Designated as safety issue: Yes ]
  • Indications of cesarean delivery [ Time Frame: Initiation of analgesia to placental delivery (approximately 8 hours) ] [ Designated as safety issue: No ]
  • Duration of analgesia [ Time Frame: Initiation of analgesia to 2 h postpartum (approximately 10 hours) ] [ Designated as safety issue: Yes ]
  • Durations of labor stages [ Time Frame: From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours) ] [ Designated as safety issue: Yes ]
  • Maternal satisfaction with analgesia [ Time Frame: At two hours postpartum ] [ Designated as safety issue: No ]
  • Use of oxytocin after analgesia [ Time Frame: At twenty-four hours postpartum ] [ Designated as safety issue: Yes ]
  • Low back pain at 3 months after vaginal delivery [ Time Frame: At the third month after vaginal delivery ] [ Designated as safety issue: Yes ]
  • Breastfeeding success at 6 weeks after vaginal delivery [ Time Frame: At the sixth week after successful delivery ] [ Designated as safety issue: Yes ]
  • Neonatal Apgar scale [ Time Frame: At the first and fifth minutes after baby was born ] [ Designated as safety issue: Yes ]
  • Incidence of maternal side effects [ Time Frame: Initiation of analgesia to 2 hour postpartum (approximately 10 hours) ] [ Designated as safety issue: Yes ]
  • Neonatal Neurologic and Adaptive Capacity Score [ Time Frame: At 30 min, 2 h, and 24 h after baby was born ] [ Designated as safety issue: Yes ]
  • Maximal oxytocin dose [ Time Frame: At twenty-four hours postpartum ] [ Designated as safety issue: Yes ]
  • Neonatal sepsis evaluation [ Time Frame: At 30 min after baby was born ] [ Designated as safety issue: Yes ]
  • Neonatal antibiotic treatment [ Time Frame: One week after baby was born ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Highest thoracic sensory level to alcohol [ Time Frame: At three hours after initiation of analgesia ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8000
Study Start Date: October 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Combined spinal-epidural analgesia Procedure: Continuous epidural infusion
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: Combined spinal-epidural analgesia Procedure: Intermittent epidural bolus
Active Comparator: 7
Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)
Procedure: Combined spinal-epidural analgesia Procedure: Intermittent epidural bolus
Active Comparator: 8
Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)
Procedure: Combined spinal-epidural analgesia Procedure: Intermittent epidural bolus

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708668

Contacts
Contact: Shanwu Feng, M.D. +86 25 52226112 shanwufeng@163.com

Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210004
Contact: Shanwu Feng, M.D.    +86 25 52226112    shanwufeng@163.com   
Principal Investigator: Shanwu Feng, M.D.         
Sponsors and Collaborators
ShanWu Feng, M.D.
Investigators
Study Director: Shanwu Feng, M.D. Nanjing Medical University
  More Information

No publications provided

Responsible Party: ShanWu Feng, M.D., Department of Anesthesiology, Nanjing Maternal and Child Health Care Hospital, Nanjing, Jiangsu, China, 210004, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01708668     History of Changes
Other Study ID Numbers: NJMCHH-2012-A010, 08NMUM063, YKK08119, YKK11058
Study First Received: October 7, 2012
Last Updated: May 2, 2013
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Fever
Patient controlled epidural analgesia
Labor analgesia
Epidural analgesia
Combined spinal-epidural analgesia

Additional relevant MeSH terms:
Labor Pain
Neurologic Manifestations
Signs and Symptoms
Nervous System Diseases
Pain

ClinicalTrials.gov processed this record on November 20, 2014