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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preemptive epidural analgesia | Experimental | Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3). |
|
| Standard of care | Active Comparator | Parturients with cervical dilatation and painful labor (VAS >5) will receive epidural analgesia as soon as possible |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preemptive epidural analgesia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Orbach-Zinger, M.D. | Department of Anesthesiology, Rabin Medical Center/Beilinson Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center/Beilinson Campus | Petah Tikva | 49100 | Israel |
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Women in labor were recruited for the study at entry to the triage area of the delivery room of a major tertiary medical center from January to May 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized to Early Epidural Analgesia | Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions |
| FG001 | Randomized to Epidural Analgesia Upon Request | Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized to Early Epidural Analgesia | Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions |
| BG001 | Randomized to Epidural Analgesia Upon Request |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment | Maternal serum cytokine IL-10 levels of pg/ml measured upon enrollment | Posted | Mean | Standard Deviation | pg/ml | Right after enrollment |
|
Adverse events were recorded throughout study participation period four months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Randomized to Early Epidural Analgesia | Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyoptension | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Leonid Edilman | Rabin Medical Center | 972-9376850 | leidelman@clalit.org.il |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Drug | Epidural analgesia with parturients with cervical dilatation and painful labor (VAS >5) |
|
Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | Posted | Mean | Standard Deviation | pg/ml | 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 | Posted | Mean | Standard Deviation | pg/ml | At birth of parturients |
|
|
|
| 0 |
| 20 |
| 9 |
| 20 |
| EG001 | Randomized to Epidural Analgesia Upon Request | Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated. | 0 | 21 | 0 | 21 |
| meconium in the amniotic fluid | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
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| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |