Clinical trial NCT01708668: The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia
Official title: The Effects of Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Fever for Labor Analgesia in Primiparous Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2012-10-17
Enrollment: 12000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

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