Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

Clalit Health Services

Status and phase: Completed; Phase 4

Conditions: Obstetric Pain

Treatments: Drug: Standard of care; Procedure: Preemptive epidural analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT00361712

003692

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Preemptive epidural analgesia

Experimental group

Description:

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

Treatment:

Procedure: Preemptive epidural analgesia

Standard of care

Active Comparator group

Description:

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

Treatment:

Drug: Standard of care