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Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

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ClinicalTrials.gov Identifier: NCT00361712
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : March 12, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
sharonorbach, Rabin Medical Center

August 6, 2006
August 8, 2006
November 24, 2016
March 12, 2018
April 9, 2018
July 2006
July 2006   (Final data collection date for primary outcome measure)
  • Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment [ Time Frame: Right after 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 [ Time Frame: 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 [ Time Frame: At birth of parturients ]
    Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery
  • Maternal cytokine levels upon enrollment
  • Maternal cytokine levels 24 hours after delivery
  • Umbilical cord cytokine levels at birth
Complete list of historical versions of study NCT00361712 on ClinicalTrials.gov Archive Site
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Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production
Effect of Preemptive Epidural Analgesia in Labor on Pro and Anti-inflammatory Cytokine Production in a Mother and a Newborn

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Obstetric Pain
  • Procedure: Preemptive epidural analgesia
    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.
  • Drug: Standard of care
    Epidural analgesia with parturients with cervical dilatation and painful labor (VAS >5)
  • Experimental: Preemptive epidural analgesia
    Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3).
    Intervention: Procedure: Preemptive epidural analgesia
  • Active Comparator: Standard of care
    Parturients with cervical dilatation and painful labor (VAS >5) will receive epidural analgesia as soon as possible
    Intervention: Drug: Standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
Not Provided
July 2006
July 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age>18
  2. Singleton pregnancy with no known fetal malformations
  3. Above or equal to 38 weeks of pregnancy

Exclusion Criteria:

  1. Systemic medical illnesses
  2. Chronic medications except for iron and vitamins
  3. Women developing fever > 380C
  4. Women with history of delivery of children with cerebral palsy
  5. History of infertility
  6. Premature contractions
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00361712
003692
No
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
Plan to Share IPD: No
sharonorbach, Rabin Medical Center
Rabin Medical Center
Not Provided
Study Director: Sharon Orbach-Zinger, M.D. Department of Anesthesiology, Rabin Medical Center/Beilinson Hospital
Rabin Medical Center
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP