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Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

Primary Purpose

Obstetric Pain

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Preemptive epidural analgesia
Standard of care
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric Pain focused on measuring Epidural, analgesia, labor, cytokines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Age>18 Singleton pregnancy with no known fetal malformations Above or equal to 38 weeks of pregnancy Exclusion Criteria: 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

Sites / Locations

  • Rabin Medical Center/Beilinson Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preemptive epidural analgesia

Standard of care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment
Maternal serum cytokine IL-10 levels of pg/ml measured upon 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
Umbilical Cord Cytokine of pg/ml IL-10 Levels at Birth
Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery

Secondary Outcome Measures

Full Information

First Posted
August 6, 2006
Last Updated
March 12, 2018
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00361712
Brief Title
Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production
Official Title
Effect of Preemptive Epidural Analgesia in Labor on Pro and Anti-inflammatory Cytokine Production in a Mother and a Newborn
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The interrelationship between vaginal labor, cytokine production, and epidural analgesia is unknown. Vaginal delivery is thought to induce a maternal inflammatory response. Though epidural analgesia during labor was found to significantly influence peripartum maternal and newborn interleukin concentrations, these studies did not address at what stage epidural analgesia was performed. Preemptive analgesia has been found to be associated with attenuated proinflammatory cytokines, at least in the postoperative period. Healthy ASA I term parturients (>37 weeks) being accepted into delivery ward and wanting epidural analgesia will be studied. Parturients will be divided into two groups: Group I- those who have painless contractions awaiting augmentation of labor. Group II- parturients with cervical dilatation and painful labor (VAS >5). Parturients in Group I will be given epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3). Parturients in Group 2 will be given epidural analgesia as soon as possible. Epidural analgesia protocol will be identical for both groups: graduated doses of bupivicaine 0.1% 15cc and 100 mcg fentanyl followed by patient controlled analgesia at a concentration of bupivicaine 0.1% and fentanyl 2 mcg/cc delivered at 10cc per hour with possible boluses of 5 cc every ten minutes. Maternal serum will be drawn before epidural insertion and 18-24 hours after delivery. Placental blood will be drawn after delivery. These blood sample will be assessed for IL-1Beta, TNF alpha, IL-1ra, IL-2, Il-6, IL-8, IL-10, IL-18. The patient's chart will be prospectively analyzed for demographic information about parturient and complications and progress of labor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Pain
Keywords
Epidural, analgesia, labor, cytokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preemptive epidural analgesia
Arm Type
Experimental
Arm Description
Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3).
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Parturients with cervical dilatation and painful labor (VAS >5) will receive epidural analgesia as soon as possible
Intervention Type
Procedure
Intervention Name(s)
Preemptive epidural analgesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard of care
Intervention Description
Epidural analgesia with parturients with cervical dilatation and painful labor (VAS >5)
Primary Outcome Measure Information:
Title
Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment
Description
Maternal serum cytokine IL-10 levels of pg/ml measured upon enrollment
Time Frame
Right after enrollment
Title
Maternal Cytokine of pg/ml IL-10 Levels 24 Hours After Delivery
Description
Maternal serum cytokine levels of pg/ml IL-10 as measured 24 hours after delivery
Time Frame
24 hours after delivery
Title
Umbilical Cord Cytokine of pg/ml IL-10 Levels at Birth
Description
Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery
Time Frame
At birth of parturients

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age>18 Singleton pregnancy with no known fetal malformations Above or equal to 38 weeks of pregnancy Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Orbach-Zinger, M.D.
Organizational Affiliation
Department of Anesthesiology, Rabin Medical Center/Beilinson Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Rabin Medical Center/Beilinson Campus
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

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