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Epidural techniques offer the advantage of being able to titrate the level, density, and duration of the blockade through the use of a catheter and are associated with relative maternal hemodynamic stability. One of the disadvantages, however, include a raise in maternal temperature that is attributed to labor epidural technique. This study will assess if decreased maternal ventilation following induction of labor analgesia causes a raise in temperature.
Fever in labor complicates up to one-third of deliveries. The etiologies of intrapartum fever are diverse and include maternal chorioamnionitis, and other infections. In addition, epidural analgesia used for pain relief in labor is associated with mild maternal temperature increase and overt fever. Originally dismissed by obstetric anesthesiologists as a clinical curiosity of little consequence, epidural-associated hyperthermia may lead to significant maternal as well as fetal or neonatal adverse effects. Observational investigations performed 2 decades ago demonstrated a gradual increase in temperature in laboring parturients with epidural analgesia not see in those electing systemic opioid analgesia or no analgesia. The epidural group showed an average increase in temperature of approximately 1 degree centigrade over 7 hours whereas temperatures in non-epidural group remained constant. No evidence of clinical infection was reported in any of the women. Many studies confirmed these raises in temperature in epidural group compared to no epidural group during labor and delivery.
Several mechanisms have been postulated with no study reaching a conclusion. The mechanisms suggested include imbalance between heat production and heat dissipation, effect of opioid on interleukin-2, markers of inflammation induced by epidural analgesia, etc. Our study aims at the first mechanism. It may be a physiological process that leads to an imbalance between heat production and heat dissipation. Labor is a hyper metabolic state and increased heat production is dissipated via increased ventilation that is associated with labor pains with no epidural pain relief. It is conceivable that laboring women with pain relief subsequent to epidural analgesia, a decrease in ventilations may occur leading to decreased heat dissipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ventilation during labor analgesia | We are simply measuring ventilation changes that occur following labor analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labor analgesia | Other | Measuring maternal ventilation after placement of epidural analgesia compared to baseline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Maternal Ventilation During Labor Analgesia | If Maternal Ventilation decreases following labor analgesia at 2 hour and 4 interval | Ventilation parameters measured at 2 hour and 4 hour |
| Measure | Description | Time Frame |
|---|---|---|
| If Maternal Temperature Increases During Labor Analgesia | If maternal temperature increases during labor analgesia | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Informed consent will be obtained by one of the licensed physician investigators at the earliest opportunity when the subject arrives on the labor suite and following contact with their provider. While the timing between subject arrival and request for neuraxial analgesia can be variable, in subjects who present in early labor at less than 5 cm cervial dilation, there is often several hours available for a subject to consider 1) whether they desire a central neuraxial technique during labor, and 2) whether they would be willing to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Bhavani Kodali, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02090 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31286333 | Derived | Kodali BS, Choi L, Chau A, Harvey BC, Brayanov J, Tsen LC, Palanisamy A. Use of a novel non-invasive respiratory monitor to study changes in pulmonary ventilation during labor epidural analgesia. J Clin Monit Comput. 2020 Jun;34(3):567-574. doi: 10.1007/s10877-019-00349-1. Epub 2019 Jul 8. |
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Following approval by our Institutional Review Board, written consent was obtained from 57 healthy, full-term women undergoing elective induction of labor who expressed interest in receiving epidural analgesia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Maternal ventilation was measured non-invasively using the ExSpiron Respiratory Volume Monitor (RVM) in forty-one term parturients who received labor epidural analgesia. Minute ventilation (MV), respiratory rate (RR), and tidal volume (TV) were measured via chest pads using bio-impedance technology. In addition, we recorded vital signs and maternal oral temperature at 5, 10, 15, 20, 25, 30 and 60 min after epidural analgesia initiation, and then every hour until delivery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | We are simply measuring ventilation changes that occur following labor analgesia. Labor analgesia: Measuring maternal ventilation after placement of epidural analgesia compared to baseline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Changes in Maternal Ventilation During Labor Analgesia | If Maternal Ventilation decreases following labor analgesia at 2 hour and 4 interval | Posted | Mean | Standard Deviation | L/min | Ventilation parameters measured at 2 hour and 4 hour |
|
Only for the study period
No adverse events observed
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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 | Ventilation During Labor Analgesia | We are simply measuring ventilation changes that occur following labor analgesia. Labor analgesia: Measuring maternal ventilation after placement of epidural analgesia compared to baseline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bhavani Kodali | Brigham and Women's Hospital | 6175258449 | bkodali@partners.org |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | If Maternal Temperature Increases During Labor Analgesia | If maternal temperature increases during labor analgesia | Posted | Mean | Standard Deviation | Degree F | 4 hours |
|
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| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
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