The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia

Browse trials for

• Neurologic Manifestations 198
• Labor Pain 395

Keywords

• Fever
• Patient controlled epidural analgesia
• Labor analgesia
• Epidural analgesia
• Combined spinal-epidural analgesia

Neurologic Manifestations

198 studies on the registry are indexed under Neurologic Manifestations; 67 are open to participants now.

This study's planned enrollment of 12,000 is above the median of 40 across 107 interventional studies indexed under Neurologic Manifestations.

Lead sponsor

This is the only study on the registry with ShanWu Feng, M.D. as lead sponsor.

Study arms

• 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

Interventions

• ProcedureEpidural analgesia
• ProcedureCombined spinal-epidural analgesia
• ProcedureContinuous epidural infusion
• ProcedureIntermittent epidural bolus

Primary outcomes

1. Maternal oral and tympanic temperature

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

Secondary outcomes

1. Maternal serum Interleukin-1β

   Time frame: At time of placental delivery and 3, 6 and 12 hours later

2. Cord serum Interleukin-1β

   Time frame: At time of placental delivery

3. Maternal serum Interleukin-6

   Time frame: At time of placental delivery and 3, 6 and 12 hours later

4. Cord serum Interleukin-6

   Time frame: At time of placental delivery

5. Maternal serum Interleukin-10

   Time frame: At time of placental delivery and 3, 6 and 12 hours later

6. Cord serum Interleukin-10

   Time frame: At time of placental delivery

7. Maternal serum tumor necrosis factor-α

   Time frame: At time of placental delivery and 3, 6 and 12 hours later

8. Cord serum tumor necrosis factor-α

   Time frame: At time of placental delivery

9. Regression and correlation analyses between maternal and cord serum cytokines

   Time frame: At twelve hours postpartum

10. Placental routine pathologic examination

    Time frame: At time of placental delivery

11. Maternal and cord blood gase analysis

    Time frame: At time of placental delivery

12. 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)

13. Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture

    Time frame: At two hours postpartum

14. Rates of cesarean delivery and instrument-assisted delivery

    Time frame: At time of placental delivery

15. Indications of cesarean delivery

    Time frame: Initiation of analgesia to placental delivery (approximately 8 hours)

16. Duration of analgesia

    Time frame: Initiation of analgesia to 2 h postpartum (approximately 10 hours)

17. Durations of labor stages

    Time frame: From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)

18. Maternal satisfaction with analgesia

    Time frame: At two hours postpartum

19. Use of oxytocin after analgesia

    Time frame: At twenty-four hours postpartum

20. Low back pain at 3 months after vaginal delivery

    Time frame: At the third month after vaginal delivery

21. Breastfeeding success at 6 weeks after vaginal delivery

    Time frame: At the sixth week after successful delivery

22. Neonatal Apgar scale

    Time frame: At the first and fifth minutes after baby was born

23. Incidence of maternal side effects

    Time frame: Initiation of analgesia to 2 hour postpartum (approximately 10 hours)

24. Neonatal Neurologic and Adaptive Capacity Score

    Time frame: At 30 min, 2 h, and 24 h after baby was born

25. Maximal oxytocin dose

    Time frame: At twenty-four hours postpartum

26. Neonatal sepsis evaluation

    Time frame: At 30 min after baby was born

27. Neonatal antibiotic treatment

    Time frame: One week after baby was born

28. 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)

29. Highest thoracic sensory level to alcohol

    Time frame: At three hours after initiation of analgesia

30. Uterine contraction

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

31. Neonatal rectal temperature

    Time frame: At delivery, 30 min after delivery, and 1 h after delivery

32. Fetal heart rate

    Time frame: From initiation of analgesia to delivery (approximately 8 hours)

33. Maternal group B streptococcus (GBS) colonization

    Time frame: At time of initiation of analgesia

34. 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)

35. Neonatal weight

    Time frame: At delivery

36. 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)

37. 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)

38. Maternal postpartum depression

    Time frame: At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year)