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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
  Purpose

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.


Condition Intervention
Obstetric Pain
Procedure: Epidural analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Preemptive Epidural Analgesia in Labor on Pro and Anti-Inflammatory Cytokine Production in a Mother and a Newborn

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Maternal cytokine levels upon enrollment
  • Maternal cytokine levels 24 hours after delivery
  • Umbilical cord cytokine levels at birth

Study Start Date: January 2006
Estimated Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361712

Locations
Israel
Rabin Medical Center/Beilinson Campus
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
Study Director: Sharon Orbach-Zinger, M.D. Department of Anesthesiology, Rabin Medical Center/Beilinson Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00361712     History of Changes
Other Study ID Numbers: 003692
Study First Received: August 6, 2006
Last Updated: August 6, 2006
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Epidural
analgesia
labor
cytokines

Additional relevant MeSH terms:
Labor Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014