Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

NCT00361712 | Completed Phase 4 Results

• 1 other identifier: 003692
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

During labor there is an increased production of inflammatory mediators called cytokines. Higher concentration of certain cytokines has been linked to adverse neonatal and maternal outcomes. Epidural analgesia is commonly performed after the parturient feels labor pain. We hypothesis that preemptive epidural analgesia (initiated before labor pain begins)can influence the production of cytokines.

Conditions

Obstetric Pain

Keywords

Epidural; analgesia; labor; cytokines

Outcome Measures

Primary Outcomes (3)

• Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment

  Maternal serum cytokine IL-10 levels of pg/ml measured upon enrollment

  Right after enrollment

• Maternal Cytokine of pg/ml IL-10 Levels 24 Hours After Delivery

  Maternal serum cytokine levels of pg/ml IL-10 as measured 24 hours after delivery

  24 hours after delivery

• Umbilical Cord Cytokine of pg/ml IL-10 Levels at Birth

  Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery

  At birth of parturients

Study Arms (2)

Preemptive epidural analgesia

EXPERIMENTAL

Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS\<3).

Procedure: Preemptive epidural analgesia

Standard of care

ACTIVE COMPARATOR

Parturients with cervical dilatation and painful labor (VAS \>5) will receive epidural analgesia as soon as possible

Drug: Standard of care

Interventions

Preemptive epidural analgesia PROCEDURE

Parturients will receive early epidural analgesia before onset of painful contractions as oppose to standard of care in which parturients receive epidural analgesia with onset of painful contractions.

Preemptive epidural analgesia

Standard of care DRUG

Epidural analgesia with parturients with cervical dilatation and painful labor (VAS \>5)

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18
• Singleton pregnancy with no known fetal malformations
• Above or equal to 38 weeks of pregnancy

You may not qualify if:

• Systemic medical illnesses
• Chronic medications except for iron and vitamins
• Women developing fever \> 380C
• Women with history of delivery of children with cerebral palsy
• History of infertility
• Premature contractions

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center/Beilinson Campus

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Labor Pain; Agnosia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr Leonid Edilman
• Organization: Rabin Medical Center

leidelman@clalit.org.il

972-9376850

Study Officials

• Sharon Orbach-Zinger, M.D.

  Department of Anesthesiology, Rabin Medical Center/Beilinson Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 6, 2006
• First Posted: August 8, 2006
• Study Start: July 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: April 9, 2018
• Results First Posted: March 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)