Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361712
Status:
COMPLETED
Last Update Posted:
2018-04-09
First Post:
2006-08-06
Brief Title:
Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Effect of Preemptive Epidural Analgesia in Labor on Pro and Anti-inflammatory Cytokine Production in a Mother and a Newborn
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 beginscan influence the production of cytokines
Epidural analgesia is commonly performed after the parturient feels labor pain
We hypothesis that preemptive epidural analgesia initiated before labor pain beginscan influence the production of cytokines
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 VAS3 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 01 15cc and 100 mcg fentanyl followed by patient controlled analgesia at a concentration of bupivicaine 01 and fentanyl 2 mcgcc 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 patients chart will be prospectively analyzed for demographic information about parturient and complications and progress of labor
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 VAS3 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 01 15cc and 100 mcg fentanyl followed by patient controlled analgesia at a concentration of bupivicaine 01 and fentanyl 2 mcgcc 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 patients chart will be prospectively analyzed for demographic information about parturient and complications and progress of labor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None