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

NCT02339389 | Completed Results

• 1 other identifier: 2014P00152
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• If Maternal Temperature Increases During Labor Analgesia

  4 hours

Study Arms (1)

ventilation during labor analgesia

We are simply measuring ventilation changes that occur following labor analgesia.

Other: Labor analgesia

Interventions

Labor analgesia OTHER

Measuring maternal ventilation after placement of epidural analgesia compared to baseline

ventilation during labor analgesia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02090, United States

Location

Related Publications (1)

• 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.

  PMID: 31286333 DERIVED

Results Point of Contact

• Title: Bhavani Kodali
• Organization: Brigham and Women's Hospital

bkodali@partners.org

6175258449

Study Officials

• Bhavani Kodali, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Chairman, Anesthesiology

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 15, 2015
• Study Start: August 14, 2014
• Primary Completion: September 2, 2016
• Study Completion: September 2, 2016
• Last Updated: March 19, 2018
• Results First Posted: March 19, 2018

Record last verified: 2017-08

Locations

US (1)