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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00987441
Other study ID # NJMU-0933MZ
Secondary ID NMUK2191
Status Completed
Phase N/A
First received September 30, 2009
Last updated July 26, 2011
Start date September 2009
Est. completion date July 2011

Study information

Verified date July 2011
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 45 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Ropivacaine and sufentanil
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Ropivacaine and sufentanil
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Ropivacaine and sufentanil
Ropivacaine 0.25% plus sufentanil 0.4 microgram

Locations

Country Name City State
China The Affiliated Nanjing Maternity and Child Health Care Hospital Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) Immediate after birth (0 min) Yes
Secondary Apgar scoring One min and 5min after birth. Yes
Secondary Umbilical-cord gases analysis At the time baby was born (0min) Yes
Secondary Neonatal sepsis evaluation One hour after the baby was born Yes
Secondary Neonatal antibiotic treatment One hour after the baby was born Yes
Secondary Incidence of maternal side effects Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women) Yes
Secondary Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) 10min after birth Yes
Secondary Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) 1h after birth Yes
Secondary Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) 8h after birth Yes
Secondary Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) 1d after birth Yes
Secondary Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) 1wk after birth Yes
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