Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

Obstetric Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361712
• Other study ID #: 003692
• Status: Completed
• Phase: Phase 4
• First received: August 6, 2006
• Last updated: March 12, 2018
• Start date: July 2006
• Est. completion date: July 2006

Study information

• Verified date: March 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain
• Obstetric Pain

Intervention

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.

Drug:
• Standard of care
Epidural analgesia with parturients with cervical dilatation and painful labor (VAS >5)

Locations

Country	Name	City	State
Israel	Rabin Medical Center/Beilinson Campus	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment	Maternal serum cytokine IL-10 levels of pg/ml measured upon enrollment	Right after enrollment
Primary	Maternal Cytokine of pg/ml IL-10 Levels 24 Hours After Delivery	Maternal serum cytokine levels of pg/ml IL-10 as measured 24 hours after delivery	24 hours after delivery
Primary	Umbilical Cord Cytokine of pg/ml IL-10 Levels at Birth	Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery	At birth of parturients