Does Maternal Fever During Labor Analgesia Has Any Relationship With Maternal Ventilation?

Pregnancy Clinical Trial

— matvent  

Official title:

Does Maternal Fever During Labor Analgesia Has Any Relationship With Maternal Ventilation?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339389
• Other study ID #: 2014P00152
• Status: Completed
• First received: January 6, 2015
• Last updated: August 27, 2017
• Start date: August 14, 2014
• Est. completion date: September 2, 2016

Study information

• Verified date: August 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2, 2016
• Est. primary completion date: September 2, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Parturient with no major co-morbidities

2. Singleton, vertex gestation at term (38-42 weeks)

3. Less than 5 cm dilation

4. Intact fetal membranes or rupture for < 6 hrs.

5. Desire to have an epidural technique for labor analgesia

Exclusion Criteria:

1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)

2. Any contraindication to the administration of an epidural technique

3. History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications

4. Current or historical evidence of a disease which may result in the risk of a cesarean delivery (i.e. vaginal birth after cesarean section, history of uterine rupture)

5. Evidence of anticipated fetal anomalies

6. Signs or symptoms consistent with an infection or sepsis; baseline temperature < 37 degrees Celsius, or 99 degrees Fahrenheit.

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Labor analgesia
Measuring maternal ventilation after placement of epidural analgesia compared to baseline

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	If Maternal Temperature Increases During Labor Analgesia	If maternal temperature increases during labor analgesia	4 hours