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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12,000
Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGMaternal oral and tympanic temperature
Time frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Maternal serum Interleukin-1β
Time frame: At time of placental delivery and 3, 6 and 12 hours later
Cord serum Interleukin-1β
Time frame: At time of placental delivery
Maternal serum Interleukin-6
Time frame: At time of placental delivery and 3, 6 and 12 hours later
Cord serum Interleukin-6
Time frame: At time of placental delivery
Maternal serum Interleukin-10
Time frame: At time of placental delivery and 3, 6 and 12 hours later
Cord serum Interleukin-10
Time frame: 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
Cord serum tumor necrosis factor-α
Time frame: At time of placental delivery
Regression and correlation analyses between maternal and cord serum cytokines
Time frame: At twelve hours postpartum
Placental routine pathologic examination
Time frame: At time of placental delivery
Maternal and cord blood gase analysis
Time frame: 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)
Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture
Time frame: At two hours postpartum
Rates of cesarean delivery and instrument-assisted delivery
Time frame: At time of placental delivery
Indications of cesarean delivery
Time frame: Initiation of analgesia to placental delivery (approximately 8 hours)
Duration of analgesia
Time frame: 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)
Maternal satisfaction with analgesia
Time frame: At two hours postpartum
Use of oxytocin after analgesia
Time frame: At twenty-four hours postpartum
Low back pain at 3 months after vaginal delivery
Time frame: At the third month after vaginal delivery
Breastfeeding success at 6 weeks after vaginal delivery
Time frame: At the sixth week after successful delivery
Neonatal Apgar scale
Time frame: At the first and fifth minutes after baby was born
Incidence of maternal side effects
Time frame: Initiation of analgesia to 2 hour postpartum (approximately 10 hours)
Neonatal Neurologic and Adaptive Capacity Score
Time frame: At 30 min, 2 h, and 24 h after baby was born
Maximal oxytocin dose
Time frame: At twenty-four hours postpartum
Neonatal sepsis evaluation
Time frame: At 30 min after baby was born
Neonatal antibiotic treatment
Time frame: 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)
Highest thoracic sensory level to alcohol
Time frame: 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)
Neonatal rectal temperature
Time frame: At delivery, 30 min after delivery, and 1 h after delivery
Fetal heart rate
Time frame: From initiation of analgesia to delivery (approximately 8 hours)
Maternal group B streptococcus (GBS) colonization
Time frame: 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)
Neonatal weight
Time frame: At delivery
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)
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)
Maternal postpartum depression
Time frame: At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year)
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