Ignite Creation Date:
2024-05-05 @ 9:49 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00970151
Status:
COMPLETED
Last Update Posted:
2009-10-12
First Post:
2008-02-19
Brief Title:
Determinants of Fetal Inflammatory Exposure at Term
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Determinants of Fetal Inflammatory Exposure at Term
Status:
COMPLETED
Status Verified Date:
2009-10
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:
The hypothesis of this study is that maternal and fetal biologic variation in the balance between pro-inflammatory and anti-inflammatory mediators can be measured by currently available techniques In addition the investigators hypothesize that a pro-inflammatory maternal phenotype increases the risk of fetal exposure to intrauterine hyperthemia and inflammatory cytokines and that intrapartum events especially known risk factors for fever at term such as epidural analgesia and prolonged rupture of membranes may interact with underlying maternal factors to increase fetal exposure to inflammatory cytokines
This experiment aims to establish the first large-scale cohort to evaluate biomarkers for maternal and fetal inflammation in term pregnancy and to elucidate the relative antepartum and intrapartum contributions to fetal inflammation
This experiment aims to establish the first large-scale cohort to evaluate biomarkers for maternal and fetal inflammation in term pregnancy and to elucidate the relative antepartum and intrapartum contributions to fetal inflammation
Detailed Description:
It has been demonstrated that intrapartum fever 1004 degrees Fahrenheit is associated with increased maternal and fetal levels of interleukin-6 IL-6 at delivery Maternal and fetal IL-6 levels are highly correlated and placental transport of cytokines has been demonstrated While intrapartum fever is traditionally attributed to acquired infection chorioamnionitis our data indicate that the maternal inflammatory balance assessed prior to the onset of labor may be a significant determinant of subsequent intrapartum fever The increased risk of neonatal brain injury may be cytokine mediated or may in part be secondary to increased vulnerability to hypoxic injury in the setting of elevated fetal brain temperature
The baseline prevalence of intrapartum fever at term is 1-5 Factors associated with an increased risk of intrapartum fever include maternal age nulliparity 75 Hispanic race induction and longer labor However in recent years the most potent risk factor for intrapartum fever has clearly been epidural analgesia - which is selected for intrapartum pain relief by the majority of mothers in the US especially in the first most painful birth We have demonstrated that the risk of fever after epidural analgesia increases with increasing duration of epidural analgesia - therefore the risk of fever after epidural analgesia is largely confined to nulliparous women Multiparous women deliver shortly after the onset of active labor resulting in a short duration of exposure to epidural analgesia and are not at increased risk Randomized studies demonstrate that the independent contribution of epidural analgesia to intrapartum fever risk is 3 to 7-fold Rates of intrapartum fever 1004 degrees Fahrenheit in nulliparas with epidural analgesia range from 145 to 33 Rates at the upper end of this range are observed in large public hospitals with primarily Hispanic populations Conversely lower rates are observed at private hospitals with primarily Caucasian populations
This study will make observations based upon
1 10 mL of blood drawn the day of enrollment
2 10 mL of blood drawn upon admission to Labor and Delivery
3 A sample of spinal fluid if a spinal epidural is chosen by the patient
4 Blood collected from the placenta and umbilical cord
In addition the mothers temperature will be taken every hour during labor
The baseline prevalence of intrapartum fever at term is 1-5 Factors associated with an increased risk of intrapartum fever include maternal age nulliparity 75 Hispanic race induction and longer labor However in recent years the most potent risk factor for intrapartum fever has clearly been epidural analgesia - which is selected for intrapartum pain relief by the majority of mothers in the US especially in the first most painful birth We have demonstrated that the risk of fever after epidural analgesia increases with increasing duration of epidural analgesia - therefore the risk of fever after epidural analgesia is largely confined to nulliparous women Multiparous women deliver shortly after the onset of active labor resulting in a short duration of exposure to epidural analgesia and are not at increased risk Randomized studies demonstrate that the independent contribution of epidural analgesia to intrapartum fever risk is 3 to 7-fold Rates of intrapartum fever 1004 degrees Fahrenheit in nulliparas with epidural analgesia range from 145 to 33 Rates at the upper end of this range are observed in large public hospitals with primarily Hispanic populations Conversely lower rates are observed at private hospitals with primarily Caucasian populations
This study will make observations based upon
1 10 mL of blood drawn the day of enrollment
2 10 mL of blood drawn upon admission to Labor and Delivery
3 A sample of spinal fluid if a spinal epidural is chosen by the patient
4 Blood collected from the placenta and umbilical cord
In addition the mothers temperature will be taken every hour during labor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 6-FY06-311 | None | None | None |