Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

• ClinicalTrials.gov Identifier: NCT00361712
• Recruitment Status: Completed
• First Posted: August 8, 2006
• Results First Posted: March 12, 2018
• Last Update Posted: April 9, 2018
• Sponsor: Rabin Medical Center
• Information provided by (Responsible Party): sharonorbach, Rabin Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obstetric Pain	Procedure: Preemptive epidural analgesia; Drug: Standard of care	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: July 2006
• Actual Primary Completion Date: July 2006
• Actual Study Completion Date: July 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

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

• Responsible Party: sharonorbach, Dr, Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT00361712
• Other Study ID Numbers: 003692
• First Posted: August 8, 2006
• Results First Posted: March 12, 2018
• Last Update Posted: April 9, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by sharonorbach, Rabin Medical Center:

Epidural; analgesia; labor; cytokines

Additional relevant MeSH terms:

Labor Pain; Pain; Neurologic Manifestations