Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

Phase 4

Completed

Conditions: Obstetric Pain

Interventions: Drug: Standard of care
Procedure: Preemptive epidural analgesia

Registration Number: NCT00361712

Lead Sponsor: Rabin Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 41

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	Parturients with cervical dilatation and painful labor (VAS \>5) will receive epidural analgesia as soon as possible
Preemptive epidural analgesia	Preemptive epidural analgesia	Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS\<3).

Primary Outcome Measures

Name	Time	Method
Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment	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	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	At birth of parturients	Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery