N/A
N=40
Pre-warming Prevents Hypothermia in Elective Cesarean Section
Hypothermia
Bottom Line
View on ClinicalTrials.gov: NCT02091466 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Maternal Hypothermia — 36.6; 36.4; 36.5; 36.3 Centigrades — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- pre-warming (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Hypothermia |
36.6; 36.4; 36.5; 36.3; 36.4; 35.9 | <0.05 sig |
Summary
Background: Hypothermia is common during general and regional anesthesia even when active warming measures are taken. The existing literature shows that, in pregnant patients, the use of forced air-warming during cesarean section under spinal anesthesia does not prevent maternal hypothermia. Therefore, this study aimed to establish the efficacy of a pre-warming system, initiated 30 minutes before the onset of spinal anesthesia and during surgery, in pregnant women subjected to elective cesarean delivery.
Methods: Forty healthy pregnant patients undergoing elective cesarean section with spinal anesthesia were allocated to the control group (Gcont, n = 20), without the use of a thermal gown, and to the gown group (Ggown, n = 20), with the use of a thermal gown in the preoperative care unit, 30 minutes before spinal anesthesia installation and during surgery. After the anesthesia, the thermal gown was moved from the regular position and placed over the chest and upper limbs, as an upper body blanket, and maintained throughout the study. The following variables were observed: preoperative and operative room temperature, hemoglobin saturation, heart rate, arterial pressure, tympanic temperature in the preoperative care unit room (baseline) and at 0, 15, 30, 45 and 60 minutes after spinal anesthesia. Repeated Measure ANCOVA compared temperatures of each group, adjusted for baseline values.
Eligibility Criteria
Inclusion Criteria
- pregnant women
- between 18 and 40 years of age
- singleton pregnancy
- gestation longer than 37 weeks
- elective cesarean section
Exclusion Criteria
- fever and/or infectious conditions
- familial history of potential malignant hyperthermia
- body mass index (BMI) values below 18.5 kg.cm-2 or above 36 kg.cm-2
- thyroid disorders, dysautonomia, Raynaud's syndrome
- patient in labor
Data sourced from ClinicalTrials.gov (NCT02091466). 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.