Epidural Labor Analgesia and Infant Neurobehavior

Labor Pain Clinical Trial

— ELAIN  

Official title:

Epidural Analgesia for Labor Pain and Infant Neurobehavior

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

• Labor Pain

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