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NCT Number: NCT00361712

Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

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.

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Key information

Conditions

Obstetric Pain Agnosia Labor Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Rabin Medical Center/Beilinson Campus

Petah Tikva, 49100, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preemptive epidural analgesia

Procedure

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.

Standard of care

Drug

Epidural analgesia with parturients with cervical dilatation and painful labor (VAS >5)

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Aug 8, 2006
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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