Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Rabin Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00361712
First received: August 6, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted

August 6, 2006
August 6, 2006
January 2006
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  • Maternal cytokine levels upon enrollment
  • Maternal cytokine levels 24 hours after delivery
  • Umbilical cord cytokine levels at birth
Same as current
No Changes Posted
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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
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstetric Pain
Procedure: Epidural analgesia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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July 2006
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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
Female
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00361712
003692
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Not Provided
Rabin Medical Center
Not Provided
Study Director: Sharon Orbach-Zinger, M.D. Department of Anesthesiology, Rabin Medical Center/Beilinson Hospital
Rabin Medical Center
July 2006

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