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

Intervention / Treatment

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

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • The Affiliated Nanjing Maternity and Child Health Care Hospital

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
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
ACTIVE_COMPARATOR: Local anesthetic plus opioid 2
Local anesthetic (ropivacaine 0.125%) plus second opioid dose (sufentanil 0.4 microgram/ml) delivered peridural space
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
ACTIVE_COMPARATOR: Local anesthetic plus opioid 3
Local anesthetic (ropivacaine 0.125%) plus third opioid dose (sufentanil 0.5 microgram/ml) delivered peridural space
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
ACTIVE_COMPARATOR: Local anesthetic 1 plus opioid
First local anesthetic dose (ropivacaine 0.0625%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
ACTIVE_COMPARATOR: Local anesthetic 2 plus opioid
Second local anesthetic dose (ropivacaine 0.1875%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
ACTIVE_COMPARATOR: Local anesthetic 3 plus opioid
Third local anesthetic dose (ropivacaine 0.25%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Drug: Ropivacaine and sufentanil
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil

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
Neonatal antibiotic treatment
Time Frame: One hour after the baby was born
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)
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
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
10min after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

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

Keywords

Additional Relevant MeSH Terms

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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