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临床试验/NCT01708668
NCT01708668Unknown不适用

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

ShanWu Feng, M.D.1 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2012年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
12,000
试验地点
1
主要终点
Maternal oral and tympanic temperature

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Nulliparous women
  • Required labor analgesia
  • Spontaneous labor

排除标准

  • 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

结局指标

主要结局

Maternal oral and tympanic temperature

时间窗: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)

次要结局

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

研究者

发起方
ShanWu Feng, M.D.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ShanWu Feng, M.D.

Department of Anesthesiology, Nanjing Maternal and Child Health Care Hospital, Nanjing, Jiangsu, China, 210004

Nanjing Medical University

研究点 (1)

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