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Trial Outcomes & Findings for Pre-warming Prevents Hypothermia in Elective Cesarean Section (NCT NCT02091466)

NCT ID: NCT02091466

Last Updated: 2015-11-02

Results Overview

Hypothermia was measured by means of tympanic temperatures.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

60 minutes

Results posted on

2015-11-02

Participant Flow

Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section, between March 18, 2010 and July 17, 2010 - assisted at the Obstetric Clinic of Santa Casa de Misericórdia de São Paulo.

Patients with fever (peripheral temperature \> 37.8 Celsius) and/or infectious conditions, familial history of potential malignant hyperthermia, body mass index (BMI) values below 18.5 Kg.m-2 or above 36 Kg.m-2, thyroid disorders, dysautonomia, Raynaud's syndrome, and those in labor were excluded.

Participant milestones

Participant milestones
Measure
Pre-warming
patients were under heating system in experimental groups heating system pre-warming: warming 30 minutes prior to anesthesia
Control
patients were under passive heating in control groups before anesthesia
Overall Study
STARTED
20
20
Overall Study
COMPLETED
20
20
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pre-warming Prevents Hypothermia in Elective Cesarean Section

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pre-warming
n=20 Participants
Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section
Control
n=20 Participants
Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section
Total
n=40 Participants
Total of all reporting groups
Age, Continuous
29.1 years
STANDARD_DEVIATION 5.9 • n=5 Participants
28.4 years
STANDARD_DEVIATION 6.0 • n=7 Participants
28.8 years
STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
20 Participants
n=7 Participants
40 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
Brazil
20 participants
n=5 Participants
20 participants
n=7 Participants
40 participants
n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Population: Sample size was calculated to be 20 subjects in each group to ensure that a difference of 0.5ºC at 60 minutes could be detected at significance level of 5% with a statistical power of 90%, assuming the standard deviation of differences to be 0.5ºC, considering a temperature below 36.0ºC could be considered hypothermia

Hypothermia was measured by means of tympanic temperatures.

Outcome measures

Outcome measures
Measure
Pre-warming
n=20 Participants
Patients were covered with a thermal gown (Bair Paws Standard Warming Gown 810 model with a Bair Hugger, model 850 warming unit) with forced-air flow at 40ºC in the preoperative care unit 30 minutes before the spinal anesthesia.
Control
n=20 Participants
Patients remained without the use of a thermal gown,
Maternal Hypothermia
30 minutes
36.2 Centigrades
Standard Deviation 0.3
35.7 Centigrades
Standard Deviation 0.4
Maternal Hypothermia
baseline
36.6 Centigrades
Standard Deviation 0.3
36.4 Centigrades
Standard Deviation 0.4
Maternal Hypothermia
time zero
36.5 Centigrades
Standard Deviation 0.3
36.3 Centigrades
Standard Deviation 0.3
Maternal Hypothermia
15 minutes
36.4 Centigrades
Standard Deviation 0.3
35.9 Centigrades
Standard Deviation 0.4
Maternal Hypothermia
45 minutes
36.2 Centigrades
Standard Deviation 0.3
35.6 Centigrades
Standard Deviation 0.3
Maternal Hypothermia
60 minutes
36.1 Centigrades
Standard Deviation 0.2
35.4 Centigrades
Standard Deviation 0.4

Adverse Events

Pre-warming

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ricardo Caio Gracco De Bernardis

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Phone: 55-11-21767280

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place