Skip to main content
OpenTrials
Completed

NCT Number: NCT02339389

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02090, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parturient with no major co-morbidities
  • Singleton, vertex gestation at term (38-42 weeks)
  • Less than 5 cm dilation
  • Intact fetal membranes or rupture for < 6 hrs.
  • Desire to have an epidural technique for labor analgesia

Exclusion criteria

  • Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
  • Any contraindication to the administration of an epidural technique
  • History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications
  • 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)
  • Evidence of anticipated fetal anomalies
  • Signs or symptoms consistent with an infection or sepsis; baseline temperature < 37 degrees Celsius, or 99 degrees Fahrenheit.

Treatment and study plan

Labor analgesia

Other

Measuring maternal ventilation after placement of epidural analgesia compared to baseline

Primary outcomes

  1. Changes in Maternal Ventilation During Labor Analgesia

    Time frame: Ventilation parameters measured at 2 hour and 4 hour

    If Maternal Ventilation decreases following labor analgesia at 2 hour and 4 interval

Secondary outcomes

  1. If Maternal Temperature Increases During Labor Analgesia

    Time frame: 4 hours

    If maternal temperature increases during labor analgesia

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Acronym: matvent

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2015
Registry last updated
Mar 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.