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Completed

NCT Number: NCT00987441

Epidural Labor Analgesia 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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine and sufentanil

Drug

Ropivacaine 0.125% plus sufentanil 0.3 microgram

Other names: Naropin, Sufenil

Primary outcomes

  1. Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Time frame: Immediate after birth (0 min)

Secondary outcomes

  1. Apgar scoring

    Time frame: One min and 5min after birth.

  2. Umbilical-cord gases analysis

    Time frame: At the time baby was born (0min)

  3. Neonatal sepsis evaluation

    Time frame: One hour after the baby was born

  4. Neonatal antibiotic treatment

    Time frame: One hour after the baby was born

  5. Incidence of maternal side effects

    Time frame: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)

  6. Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Time frame: 10min after birth

  7. Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Time frame: 1h after birth

  8. Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Time frame: 8h after birth

  9. Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Time frame: 1d after birth

  10. Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Time frame: 1wk after birth

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

Epidural Analgesia for Labor Pain and Infant Neurobehavior

Acronym: ELAIN

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 1, 2009
Registry last updated
Jul 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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