N/A
N=57
Does Maternal Fever During Labor Analgesia Has Any Relationship With Maternal Ventilation?
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02339389 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Changes in Maternal Ventilation During Labor Analgesia — 15.3; 12.6; 13.8 L/min
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Labor analgesia (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Maternal Ventilation During Labor Analgesia |
15.3; 12.6; 13.8 | — |
| SECONDARY If Maternal Temperature Increases During Labor Analgesia |
98.1; 98.7 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02339389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.