Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03473470
Study type Interventional
Source University of Foggia
Contact Antonella Cotoia, MD
Phone +393297174175
Email antonella.cotoia@unifg.it
Status Recruiting
Phase N/A
Start date December 22, 2016
Completion date November 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT05292937 - Incidence of Perioperative Hypothermia in Pediatric Patients
Completed NCT05516771 - Evaluation of a Licensed Double-sensor-heat-flux (DHF) Non-invasive Core Temperature Sensor in Small Children and Toddlers Undergoing Surgery
Not yet recruiting NCT05426278 - The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting N/A
Completed NCT06010069 - The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores
Completed NCT03157609 - Can the SpotOn™ Zero-Heat-Flux-Thermometry Sensor Accurately Measure Core Temperature in Children? N/A
Recruiting NCT05349734 - Comparison of Underbody and Overbody Forced Air Blanket in Pediatric Patients Undergoing Cardiovascular Interventions N/A
Completed NCT04996407 - Survival Thermal Blanket Versus Draping Fabric to Prevent Hypothermia in Geriatric Surgical Patients N/A
Completed NCT03111875 - Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery N/A
Completed NCT03527329 - Perioperative Hypothermia in Patients Submitted to Transurethral Resection
Not yet recruiting NCT05958550 - A Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery
Completed NCT05215834 - The Comparison of Remimazolam With Propofol in Core Body Temperature Phase 4
Completed NCT04252820 - Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia N/A
Completed NCT04935632 - Perioperative Collection of Temperatures and Hypothermia
Completed NCT04709627 - enFlow IV Fluid and Blood Warming System
Not yet recruiting NCT05430997 - Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery N/A
Completed NCT04027842 - Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia N/A
Completed NCT05213377 - Preoperative Warming, Hypothermia and Functional Recovery in Total Hip Arthroplasty N/A
Completed NCT04686214 - Body Temperature and Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery N/A
Recruiting NCT04410068 - Comparison of Electric Heating Pad Versus Forced-air Warming to Prevent Inadvertent Perioperative Hypothermia N/A
Completed NCT04033900 - Effects of Active Prewarming in Perioperative Hypothermia in Adults N/A