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Epidural Labor Analgesia and Infant Neurobehavior

NCT00987441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2011-07-27

No results posted yet for this study

Summary

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.

Conditions

  • Labor Pain

Interventions

DRUG

Ropivacaine and sufentanil

Ropivacaine 0.125% plus sufentanil 0.3 microgram

DRUG

Ropivacaine and sufentanil

Ropivacaine 0.125% plus sufentanil 0.4 microgram

DRUG

Ropivacaine and sufentanil

Ropivacaine 0.125% plus sufentanil 0.5 microgram

DRUG

Ropivacaine and sufentanil

Ropivacaine 0.0625% plus sufentanil 0.4 microgram

DRUG

Ropivacaine and sufentanil

Ropivacaine 0.1875% plus sufentanil 0.4 microgram

DRUG

Ropivacaine and sufentanil

Ropivacaine 0.25% plus sufentanil 0.4 microgram

Sponsors & Collaborators

  • Nanjing Medical University

    lead OTHER

Principal Investigators

  • XiaoFeng Shen, MD · Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00987441 on ClinicalTrials.gov