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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01708668
Other study ID # NJMCHH-2012-A010
Secondary ID 08NMUM063YKK0811
Status Recruiting
Phase N/A
First received October 7, 2012
Last updated January 14, 2015
Start date October 2012
Est. completion date June 2017

Study information

Verified date January 2015
Source Nanjing Medical University
Contact Shanwu Feng, M.D.
Phone +86 25 52226112
Email shanwufeng@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12000
Est. completion date June 2017
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Epidural analgesia

Combined spinal-epidural analgesia

Continuous epidural infusion

Intermittent epidural bolus


Locations

Country Name City State
China Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
ShanWu Feng, M.D.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maternal oral and tympanic temperature At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours) Yes
Secondary Maternal serum Interleukin-1ß At time of placental delivery and 3, 6 and 12 hours later No
Secondary Cord serum Interleukin-1ß At time of placental delivery No
Secondary Maternal serum Interleukin-6 At time of placental delivery and 3, 6 and 12 hours later No
Secondary Cord serum Interleukin-6 At time of placental delivery No
Secondary Maternal serum Interleukin-10 At time of placental delivery and 3, 6 and 12 hours later No
Secondary Cord serum Interleukin-10 At time of placental delivery No
Secondary Maternal serum tumor necrosis factor-a At time of placental delivery and 3, 6 and 12 hours later No
Secondary Cord serum tumor necrosis factor-a At time of placental delivery No
Secondary Regression and correlation analyses between maternal and cord serum cytokines At twelve hours postpartum No
Secondary Placental routine pathologic examination At time of placental delivery No
Secondary Maternal and cord blood gase analysis At time of placental delivery No
Secondary Maternal modified Bromage scale and visual analogue scale At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours) No
Secondary Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture At two hours postpartum No
Secondary Rates of cesarean delivery and instrument-assisted delivery At time of placental delivery Yes
Secondary Indications of cesarean delivery Initiation of analgesia to placental delivery (approximately 8 hours) No
Secondary Duration of analgesia Initiation of analgesia to 2 h postpartum (approximately 10 hours) Yes
Secondary Durations of labor stages From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours) Yes
Secondary Maternal satisfaction with analgesia At two hours postpartum No
Secondary Use of oxytocin after analgesia At twenty-four hours postpartum Yes
Secondary Low back pain at 3 months after vaginal delivery At the third month after vaginal delivery Yes
Secondary Breastfeeding success at 6 weeks after vaginal delivery At the sixth week after successful delivery Yes
Secondary Neonatal Apgar scale At the first and fifth minutes after baby was born Yes
Secondary Incidence of maternal side effects Initiation of analgesia to 2 hour postpartum (approximately 10 hours) Yes
Secondary Neonatal Neurologic and Adaptive Capacity Score At 30 min, 2 h, and 24 h after baby was born Yes
Secondary Maximal oxytocin dose At twenty-four hours postpartum Yes
Secondary Neonatal sepsis evaluation At 30 min after baby was born Yes
Secondary Neonatal antibiotic treatment One week after baby was born Yes
Secondary Maternal heart rate, respiratory rate, and blood pressure At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours) Yes
Secondary Highest thoracic sensory level to alcohol At three hours after initiation of analgesia Yes
Secondary Uterine contraction At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours) Yes
Secondary Neonatal rectal temperature At delivery, 30 min after delivery, and 1 h after delivery Yes
Secondary Fetal heart rate From initiation of analgesia to delivery (approximately 8 hours) Yes
Secondary Maternal group B streptococcus (GBS) colonization At time of initiation of analgesia Yes
Secondary 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) Yes
Secondary Neonatal weight At delivery No
Secondary 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) Yes
Secondary 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) No
Secondary Maternal postpartum depression At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year) Yes
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