- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00987441
Epidural Labor Analgesia and Infant Neurobehavior (ELAIN)
July 26, 2011 updated by: Nanjing Medical University
Epidural Analgesia for Labor Pain and Infant Neurobehavior
Infant neurobehavior alteration is predictor of later intelligence development.
Many factors would influence or are associated with infant neurobehavior, of which exist or appear during perinatal period.
Neuraxial, especially epidural, analgesia to date is the most effective method in relieving labor pain.
Although previous studies showed that opioid used in epidural analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation associated manner, whether epidural analgesia itself would produce unpredictable effect on newborn neurobehavior is still unknown.
Hereby the investigators designed this trial to investigate the hypothesis that epidural analgesia for labor pain control itself would not produce negative effect on infant neurobehavior.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
1200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210004
- The Affiliated Nanjing Maternity and Child Health Care Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- >18years and <45years
- Spontaneous labor
- Analgesia request
Exclusion Criteria:
- Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
- Participants younger than 18 years or older than 45 years
- 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 were excluded for their influence on the analgesic efficacy of the epidural analgesics
- Subjects with a nonvertex presentation or scheduled induction of labor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Local anesthetic plus opioid 1
Local anesthetic (ropivacaine 0.125%) plus first opioid dose (sufentanil 0.3 microgram/ml) delivered peridural space
|
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
|
ACTIVE_COMPARATOR: Local anesthetic plus opioid 2
Local anesthetic (ropivacaine 0.125%) plus second opioid dose (sufentanil 0.4 microgram/ml) delivered peridural space
|
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
|
ACTIVE_COMPARATOR: Local anesthetic plus opioid 3
Local anesthetic (ropivacaine 0.125%) plus third opioid dose (sufentanil 0.5 microgram/ml) delivered peridural space
|
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
|
ACTIVE_COMPARATOR: Local anesthetic 1 plus opioid
First local anesthetic dose (ropivacaine 0.0625%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
|
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
|
ACTIVE_COMPARATOR: Local anesthetic 2 plus opioid
Second local anesthetic dose (ropivacaine 0.1875%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
|
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
|
ACTIVE_COMPARATOR: Local anesthetic 3 plus opioid
Third local anesthetic dose (ropivacaine 0.25%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
|
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time Frame: Immediate after birth (0 min)
|
Immediate after birth (0 min)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Apgar scoring
Time Frame: One min and 5min after birth.
|
One min and 5min after birth.
|
Umbilical-cord gases analysis
Time Frame: At the time baby was born (0min)
|
At the time baby was born (0min)
|
Neonatal sepsis evaluation
Time Frame: One hour after the baby was born
|
One hour after the baby was born
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Neonatal antibiotic treatment
Time Frame: One hour after the baby was born
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One hour after the baby was born
|
Incidence of maternal side effects
Time Frame: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)
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Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)
|
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time Frame: 1h after birth
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1h after birth
|
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time Frame: 8h after birth
|
8h after birth
|
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time Frame: 1d after birth
|
1d after birth
|
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time Frame: 1wk after birth
|
1wk after birth
|
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time Frame: 10min after birth
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10min after birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (ACTUAL)
July 1, 2011
Study Completion (ACTUAL)
July 1, 2011
Study Registration Dates
First Submitted
September 30, 2009
First Submitted That Met QC Criteria
September 30, 2009
First Posted (ESTIMATE)
October 1, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
July 27, 2011
Last Update Submitted That Met QC Criteria
July 26, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Labor Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Ropivacaine
- Sufentanil
- Dsuvia
Other Study ID Numbers
- NJMU-0933MZ
- NMUK2191
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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