Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Preemptive Epidural Analgesia in Labor on Pro and Anti-inflammatory Cytokine Production in a Mother and a Newborn

Conditions
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Obstetric Pain

Intervention / Treatment
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* Procedure: Preemptive epidural analgesia
* Drug: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preemptive epidural analgesia<br>Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3). | Procedure: Preemptive epidural analgesia<br>* 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.<br>|
| Active Comparator: Standard of care<br>Parturients with cervical dilatation and painful labor (VAS >5) will receive epidural analgesia as soon as possible | Drug: Standard of care<br>* Epidural analgesia with parturients with cervical dilatation and painful labor (VAS >5)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural, analgesia, labor, cytokines