NCT00987441

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 27, 2011

Status Verified

July 1, 2011

Enrollment Period

1.8 years

First QC Date

September 30, 2009

Last Update Submit

July 26, 2011

Conditions

Labor Pain

Keywords

NeurobehaviorEpidural analgesiaLocal anestheticOpioid

Outcome Measures

Primary Outcomes (1)

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

    Immediate after birth (0 min)

Secondary Outcomes (10)

  • Apgar scoring

    One min and 5min after birth.

  • Umbilical-cord gases analysis

    At the time baby was born (0min)

  • Neonatal sepsis evaluation

    One hour after the baby was born

  • Neonatal antibiotic treatment

    One hour after the baby was born

  • Incidence of maternal side effects

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

  • +5 more secondary outcomes

Study Arms (6)

Local anesthetic plus opioid 1

ACTIVE COMPARATOR

Local anesthetic (ropivacaine 0.125%) plus first opioid dose (sufentanil 0.3 microgram/ml) delivered peridural space

Drug: Ropivacaine and sufentanil

Local anesthetic plus opioid 2

ACTIVE COMPARATOR

Local anesthetic (ropivacaine 0.125%) plus second opioid dose (sufentanil 0.4 microgram/ml) delivered peridural space

Drug: Ropivacaine and sufentanil

Local anesthetic plus opioid 3

ACTIVE COMPARATOR

Local anesthetic (ropivacaine 0.125%) plus third opioid dose (sufentanil 0.5 microgram/ml) delivered peridural space

Drug: Ropivacaine and sufentanil

Local anesthetic 1 plus opioid

ACTIVE COMPARATOR

First local anesthetic dose (ropivacaine 0.0625%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space

Drug: Ropivacaine and sufentanil

Local anesthetic 2 plus opioid

ACTIVE COMPARATOR

Second local anesthetic dose (ropivacaine 0.1875%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space

Drug: Ropivacaine and sufentanil

Local anesthetic 3 plus opioid

ACTIVE COMPARATOR

Third local anesthetic dose (ropivacaine 0.25%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space

Drug: Ropivacaine and sufentanil

Interventions

Ropivacaine and sufentanilDRUG

Ropivacaine 0.125% plus sufentanil 0.3 microgram

Also known as: Naropin, Sufenil
Local anesthetic plus opioid 1

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \>18years and \<45years
  • Spontaneous labor
  • Analgesia request

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Labor Pain

Interventions

RopivacaineSufentanil

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 1, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 27, 2011

Record last verified: 2011-07

Locations

CN(1)