Phase 4
N=41
Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production
Obstetric Pain
Bottom Line
View on ClinicalTrials.gov: NCT00361712 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment — 12.7; 14.2 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Preemptive epidural analgesia (Procedure); Standard of care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Rabin Medical Center
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment |
12.7; 14.2 | — |
| PRIMARY Maternal Cytokine of pg/ml IL-10 Levels 24 Hours After Delivery |
15.22; 16.77 | — |
| PRIMARY Umbilical Cord Cytokine of pg/ml IL-10 Levels at Birth |
1; 1.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age>18
- Singleton pregnancy with no known fetal malformations
- Above or equal to 38 weeks of pregnancy
Exclusion Criteria
- Systemic medical illnesses
- Chronic medications except for iron and vitamins
- Women developing fever > 380C
- Women with history of delivery of children with cerebral palsy
- History of infertility
- Premature contractions
Data sourced from ClinicalTrials.gov (NCT00361712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.