This trial is active, not recruiting.

Condition obstetric pain
Treatment epidural analgesia
Sponsor Rabin Medical Center
Start date January 2006
End date July 2006
Trial identifier NCT00361712, 003692


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Maternal cytokine levels upon enrollment
time frame:
Maternal cytokine levels 24 hours after delivery
time frame:
Umbilical cord cytokine levels at birth
time frame:

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Effect of Preemptive Epidural Analgesia in Labor on Pro and Anti-Inflammatory Cytokine Production in a Mother and a Newborn
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2006.
Information provided to ClinicalTrials.gov by Rabin Medical Center.