Labor PainEIEBFLANCT01708668
The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia
A study testing Epidural analgesia, Combined spinal-epidural analgesia and Continuous epidural infusion in people with Labor Pain and Pain, run by ShanWu Feng, M.D. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Labor Pain, Pain, Neurologic Manifestations
- What is being tested?
- Epidural analgesia, Combined spinal-epidural analgesia and Continuous epidural infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous women
- Required labor analgesia
- Chinese
- Spontaneous labor
Who cannot join
- 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
Show all 9Show fewer
- Alcohol addictive or narcotic dependent patients
- Subjects with a nonvertex presentation or scheduled induction of labor
- Twin gestation and breech presentation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210004
Shanwu Feng, M.D., +86 25 52226112, shanwufeng@163.com
Shanwu Feng, M.D.
About this study
Official title: The Effects of Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Fever for Labor Analgesia in Primiparous Women
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.
- Conditions
- Labor Pain, Pain, Neurologic Manifestations, Signs and Symptoms, Pathological Conditions, Signs and Symptoms
- Being tested
- Epidural analgesia, Combined spinal-epidural analgesia, Continuous epidural infusion, Intermittent epidural bolus
- Keywords
- Fever, Patient controlled epidural analgesia, Labor analgesia, Epidural analgesia, Combined spinal-epidural analgesia
- Medical subject headings
- Labor Pain, Pain, Neurologic Manifestations, Signs and Symptoms, Pathological Conditions, Signs and Symptoms, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesiaProcedure or surgery
Combined spinal-epidural analgesiaProcedure or surgery
Continuous epidural infusionProcedure or surgery
Intermittent epidural bolusProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Epidural analgesia (EA) with continuous epidural infusion(CEI) Receives: Procedure: Epidural analgesia; Procedure: Continuous epidural infusion |
| 2 | Active comparator | Combined spinal-epidural analgesia (CSEA) with continuous epidural infusion(CEI) Receives: Procedure: Combined spinal-epidural analgesia; Procedure: Continuous epidural infusion |
| 3 | Active comparator | Epidural analgesia (EA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes) Receives: Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus |
| 4 | Active comparator | Epidural analgesia (EA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes) Receives: Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus |
| 5 | Active comparator | Epidural analgesia (EA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes) Receives: Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus |
| 6 | Active comparator | Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes) Receives: Procedure: Combined spinal-epidural analgesia; Procedure: Intermittent epidural bolus |
| 7 | Active comparator | Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes) Receives: Procedure: Combined spinal-epidural analgesia; Procedure: Intermittent epidural bolus |
| 8 | Active comparator | Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes) Receives: Procedure: Combined spinal-epidural analgesia; Procedure: Intermittent epidural bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal oral and tympanic temperature
Measured: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Secondary outcomes (38)
Maternal serum Interleukin-1β
Measured: At time of placental delivery and 3, 6 and 12 hours later
Cord serum Interleukin-1β
Measured: At time of placental delivery
Maternal serum Interleukin-6
Measured: At time of placental delivery and 3, 6 and 12 hours later
Cord serum Interleukin-6
Measured: At time of placental delivery
Maternal serum Interleukin-10
Measured: At time of placental delivery and 3, 6 and 12 hours later
Cord serum Interleukin-10
Measured: At time of placental delivery
Maternal serum tumor necrosis factor-α
Measured: At time of placental delivery and 3, 6 and 12 hours later
Cord serum tumor necrosis factor-α
Measured: At time of placental delivery
Regression and correlation analyses between maternal and cord serum cytokines
Measured: At twelve hours postpartum
Placental routine pathologic examination
Measured: At time of placental delivery
Maternal and cord blood gase analysis
Measured: At time of placental delivery
Maternal modified Bromage scale and visual analogue scale
Measured: 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
Measured: At two hours postpartum
Rates of cesarean delivery and instrument-assisted delivery
Measured: At time of placental delivery
Indications of cesarean delivery
Measured: Initiation of analgesia to placental delivery (approximately 8 hours)
Duration of analgesia
Measured: Initiation of analgesia to 2 h postpartum (approximately 10 hours)
Durations of labor stages
Measured: From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)
Maternal satisfaction with analgesia
Measured: At two hours postpartum
Use of oxytocin after analgesia
Measured: At twenty-four hours postpartum
Low back pain at 3 months after vaginal delivery
Measured: At the third month after vaginal delivery
Breastfeeding success at 6 weeks after vaginal delivery
Measured: At the sixth week after successful delivery
Neonatal Apgar scale
Measured: At the first and fifth minutes after baby was born
Incidence of maternal side effects
Measured: Initiation of analgesia to 2 hour postpartum (approximately 10 hours)
Neonatal Neurologic and Adaptive Capacity Score
Measured: At 30 min, 2 h, and 24 h after baby was born
Maximal oxytocin dose
Measured: At twenty-four hours postpartum
Neonatal sepsis evaluation
Measured: At 30 min after baby was born
Neonatal antibiotic treatment
Measured: One week after baby was born
Maternal heart rate, respiratory rate, and blood pressure
Measured: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Highest thoracic sensory level to alcohol
Measured: At three hours after initiation of analgesia
Uterine contraction
Measured: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Neonatal rectal temperature
Measured: At delivery, 30 min after delivery, and 1 h after delivery
Fetal heart rate
Measured: From initiation of analgesia to delivery (approximately 8 hours)
Maternal group B streptococcus (GBS) colonization
Measured: At time of initiation of analgesia
Number of vaginal examinations, duration from rupture of the membranes to delivery, mode of membranes ruptured
Measured: From initiation of analgesia to delivery (approximately 8 hours)
Neonatal weight
Measured: At delivery
Uterine artery, umbilical artery and vein, fetus middle cerebral artery by ultrasound
Measured: 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
Measured: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Maternal postpartum depression
Measured: At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2015 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShanWu Feng, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ShanWu Feng, M.D., Nanjing Medical University
- Investigators
- Shanwu Feng, M.D., Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708668
- Sponsor's protocol ID
- NJMCHH-2012-A010
- Other IDs
- 08NMUM063, YKK08119, YKK11058
- Acronym
- EIEBFLA
- Status last verified
- Jan 2015
- First submitted
- 7 Oct 2012
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Fever for Labor Analgesia in Primiparous Women
- ClinicalTrials.gov ID
- NCT01708668
- Acronym / sponsor ID
- EIEBFLA / NJMCHH-2012-A010
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- ShanWu Feng, M.D.University, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Epidural analgesia, Procedure: Continuous epidural infusionEpidural analgesia (EA) with continuous epidural infusion(CEI) |
| 2 | Active comparator | Procedure: Combined spinal-epidural analgesia, Procedure: Continuous epidural infusionCombined spinal-epidural analgesia (CSEA) with continuous epidural infusion(CEI) |
| 3 | Active comparator | Procedure: Epidural analgesia, Procedure: Intermittent epidural bolusEpidural analgesia (EA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes) |
| 4 | Active comparator | Procedure: Epidural analgesia, Procedure: Intermittent epidural bolusEpidural analgesia (EA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes) |
| 5 | Active comparator | Procedure: Epidural analgesia, Procedure: Intermittent epidural bolusEpidural analgesia (EA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes) |
| 6 | Active comparator | Procedure: Combined spinal-epidural analgesia, Procedure: Intermittent epidural bolusCombined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes) |
| 7 | Active comparator | Procedure: Combined spinal-epidural analgesia, Procedure: Intermittent epidural bolusCombined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes) |
| 8 | Active comparator | Procedure: Combined spinal-epidural analgesia, Procedure: Intermittent epidural bolusCombined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nulliparous women
- Required labor analgesia
- Chinese
- Spontaneous labor
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural analgesia | Procedure or surgery | 1, 3, 4, 5 |
| Combined spinal-epidural analgesia | Procedure or surgery | 2, 6, 7, 8 |
| Continuous epidural infusion | Procedure or surgery | 1, 2 |
| Intermittent epidural bolus | Procedure or surgery | 3, 4, 5, 6, 7, 8 |
Primary outcome
Maternal oral and tympanic temperature
Time frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
38 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
Related trials for Labor Pain
Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanwu Feng, M.D. study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural analgesia, Combined spinal-epidural analgesia and Continuous epidural infusion in people with Labor Pain and Pain, run by ShanWu Feng, M.D. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanwu Feng, M.D. (+86 25 52226112, shanwufeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal oral and tympanic temperature (time frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2015.