Evaluation of the Active Warming Effects on Maternal and Neonatal Outcome During Cesarean Delivery
Primary Purpose
Hypothermia; Anesthesia
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
forced air warming and warmed intravenous fluids
warmed intravenous fluids
Sponsored by
About this trial
This is an interventional other trial for Hypothermia; Anesthesia focused on measuring Maternal and Neonatal Hypothermia, cesarean delivery
Eligibility Criteria
Inclusion Criteria: all healthy parturients over eighteen years undergoing cesarean delivery
Exclusion Criteria:
- Fever;
- Diabetes mellitus;
- BMI> 40Kg/m²;
- Coaugulation disorders;
- Pre-eclampsia and eclampsia;
- Increased risk of intraoperative hemorrhage
Sites / Locations
- Ospedali RiunitiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
not warmed
warmed group 1
warmed group 2
Arm Description
Not warming system
forced air warming and warmed intravenous fluids
warmed intravenous fluids
Outcomes
Primary Outcome Measures
incidence of hypothermia (body temperature < 36°C)
to assess the incidence of maternal hypothermia during caesarean delivery
Secondary Outcome Measures
Incidence of maternal shivering
Use of the Bedside shivering scale (score 0 no shiver, score 1 mild shiver at the neck or thorax, score 2 moderate shiver at the neck, thorax and arms, score 3 severe shiver at the neck, thorax, arms and legs. Score 2 and 3 are the worse outcomes
Neonatal body temperature (T°C)
with axillary thermometer
Neonatal Apgar score
Measurement of Apgar score
Incidence of maternal coagulative disorders
Thromboelastography
maternal thermal comfort
Use of a VAS 0-100 scale (100=insufferably hot, 50=thermoneutral and 0=unimaginably cold); 50 thermoneutral is the better outcome cold, 0=thermally neutral, +50=insufferably hot
Full Information
NCT ID
NCT03473470
First Posted
February 27, 2018
Last Updated
September 11, 2020
Sponsor
University of Foggia
1. Study Identification
Unique Protocol Identification Number
NCT03473470
Brief Title
Evaluation of the Active Warming Effects on Maternal and Neonatal Outcome During Cesarean Delivery
Official Title
Evaluation of the Active Warming Effects on Maternal and Neonatal Outcomes During Cesarean Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 22, 2016 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Foggia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A prospective randomized study of healthy term parturients undergoing cesarean delivery was designed to assess the impact of the active warming on perioperative and postoperative temperature.
The main objective is to evaluate the maternal core temperature in the perioperative and postoperative period during cesarean delivery.
The secondary objectives are to assess the incidence of maternal hypothermia, the incidence of maternal shivers, the evaluation of maternal thermal comfort, the neonatal temperature at birth, the Apgar score at 1 and 5 minutes, the umbilical pH, the evaluation of coagulative assessment in case of maternal hypothermia trough the use of thromboelastography.
The patients are randomized into three groups: a group of no warmed patients, a second group of Active waming patients with iv fluids and lower body forced air warming and a third group of Active warming patients with only warmed iv fluids.
The inclusion criteria are healthy parturients up to age 18. The exclusion criteria included parturients who develop fever, diabetes mellitus, BMI up to 40kg/ m2, coagulative disorders, pre eclampsia or eclampsia, all the factors that can cause intraoperative bleeding such as placental abruption or antecedent placenta overgrowth ( placenta previa).
Detailed Description
The doctor's main purposes during the perioperative period are the monitorign and maintenance of normothermia, as well as the haemodynamic, respiratory, metabolic, analgesic control and monitoring.
Mild hypothermia ( core temperature between 36° and 33° C) is common during general, locoregional or blended anaesthesia. A mild hypothermia can cause a cardiovascular, haematological, metaolic and hormonal alterations that can explain an increased mortality and morbidity in hypothermia patients versus normothermia patients.
Thermic decrease is a physiological event during general or locoregional anaesthesia. Particularly spinal and epidural anaesthesia can cause the thermic decrease because of vasodilation below the level of the sensitive and neuroaxial blockade. In this way there is in the patient an increased heat loss trough radiation. The neuroaxial techniques can reduce the sensory connections and the level of vasoconstriction above the level of the sensorial blockade, reducing the patient capacity to maintain the poichilothermia.
The consequences of hypothermia are important because they can influence the intraoperative management causing complications extending the recovering time and the hospitalization.
The environmental temperature is a critical factor for the development of hypothermia , especially in critically patients. In order to avoid the deveopment of hypothermia the environmental temperature must be maintainde between 21° and 24° C and humidity level of 40- 60%.
Maternal hypothermia is common during cesarean delivery and it can exercise influence over neonatal temperature.
When a mother develops hypothermia the newborn can shows hypotheria, umbilical acidosis, low Apgar score at birth.
The recorded data are the demographic data of the patient such as weight, age and height, the vital signs such as heart rate, arterial pressure, SpO2 or EtCO2 during general anaesthesia, BMI, gestational age and parity, type of anaesthesia, doses and type of anaesthetic used, the development of adverse effects such as hypothermia or hypothension, the blood leaks, the environmental temperature on operative theatre, the temperature of fluids iv in the perioperative period, the maternal core temperature at preoperative, during induction of anaesthesia, after 5 minutes initiating anaesthesia, and then every 10 minutes until the end of the cesarean delivery and also at child birth, at the exit of operative theatre. Maternal temperature measurment will be obtained by using a skin sensor Spot On on a temporal region, the neonatal axillary temperature at 1 and5 minutes from birth using a digital thermometer, Apgar score and umbilical cord blood pH, the pain evaluation using a VAS scale ( 0-10), the maternal shivering by the Bedside Shivering Assessment scale, the maternal comfort using a verbal numerical scale ( 0 = as worst immaginable cold 50= as thermoneutral and 100= as insufferably hot), the timing of pain at induction of anaesthesia and then every 10 minutes until the operative room exit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia
Keywords
Maternal and Neonatal Hypothermia, cesarean delivery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
not warmed
Arm Type
No Intervention
Arm Description
Not warming system
Arm Title
warmed group 1
Arm Type
Active Comparator
Arm Description
forced air warming and warmed intravenous fluids
Arm Title
warmed group 2
Arm Type
Active Comparator
Arm Description
warmed intravenous fluids
Intervention Type
Device
Intervention Name(s)
forced air warming and warmed intravenous fluids
Intervention Description
Use of warming system (forced air)
Intervention Type
Device
Intervention Name(s)
warmed intravenous fluids
Intervention Description
Use of warming system to have warmed intravenous fluids
Primary Outcome Measure Information:
Title
incidence of hypothermia (body temperature < 36°C)
Description
to assess the incidence of maternal hypothermia during caesarean delivery
Time Frame
From the date of randomization until the end of surgery, up to four hours of surgery
Secondary Outcome Measure Information:
Title
Incidence of maternal shivering
Description
Use of the Bedside shivering scale (score 0 no shiver, score 1 mild shiver at the neck or thorax, score 2 moderate shiver at the neck, thorax and arms, score 3 severe shiver at the neck, thorax, arms and legs. Score 2 and 3 are the worse outcomes
Time Frame
From the date of randomization until the end of surgery, up to four hours of surgery
Title
Neonatal body temperature (T°C)
Description
with axillary thermometer
Time Frame
From neonatal birth until five minutes after the birth
Title
Neonatal Apgar score
Description
Measurement of Apgar score
Time Frame
From neonatal birth and until five minutes after the birth
Title
Incidence of maternal coagulative disorders
Description
Thromboelastography
Time Frame
From the date of randomization until the end of surgery, up to four hours of surgery
Title
maternal thermal comfort
Description
Use of a VAS 0-100 scale (100=insufferably hot, 50=thermoneutral and 0=unimaginably cold); 50 thermoneutral is the better outcome cold, 0=thermally neutral, +50=insufferably hot
Time Frame
From the date of randomization until the end of surgery, up to four hours of surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all healthy parturients over eighteen years undergoing cesarean delivery
Exclusion Criteria:
Fever;
Diabetes mellitus;
BMI> 40Kg/m²;
Coaugulation disorders;
Pre-eclampsia and eclampsia;
Increased risk of intraoperative hemorrhage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonella Cotoia, MD
Phone
+393297174175
Email
antonella.cotoia@unifg.it
First Name & Middle Initial & Last Name or Official Title & Degree
Gilda Cinnella, MD
Email
gilda.cinnella@unifg.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonella Cotoia, MD
Organizational Affiliation
University of Foggia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedali Riuniti
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonella Cotoia, MD
Phone
+39 3297174175
Email
antonella.cotoia@unifg.it
First Name & Middle Initial & Last Name & Degree
Gilda Cinnella, MD
Email
gilda.cinnella@unifg.it
First Name & Middle Initial & Last Name & Degree
Claudia Ferialdi, MD
First Name & Middle Initial & Last Name & Degree
Antonella Matera, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of the Active Warming Effects on Maternal and Neonatal Outcome During Cesarean Delivery
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