Impact of Active Heating on Maternal and Neonatal Well-being

Hypothermia Clinical Trial

Official title:

The Effect of Usıng Heated Intravenous Fluıds wıth Underbody Warmers on Maternal and Neonatal Well-Beıng in Cesarean Sectıon Operatıons

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06259942
• Other study ID #: Surgery-01
• Status: Completed
• Phase: N/A
• Start date: June 19, 2022
• Est. completion date: September 22, 2022

Study information

• Verified date: February 2024
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to determine the effects of actively warming the patient and using warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being

Description:

This study was conducted to determine the effects of actively warming the patient and using warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being. The study was conducted in a university hospital with a total of 105 women who gave birth by cesarean section randomly selected from 35 intervention 1 (only underbody heater group), 35 intervention 2 (both underbody heater and heated IV fluid group) and 35 control group. The research data were collected with the Individual Information Form, Patient Follow-up Form and Visual Analog Scale. APGAR score, body temperature, cortisol and glucose levels were evaluated in the infant and body temperature, intraoperative bleeding, shivering, postoperative pain, gas and urination were evaluated in the mother between the three groups. Descriptive statistics, Chi-square, Shapiro Wilks, Friedman, Wilxocon, Kuruskal Wallis and Mann Whitney U test were used in the evaluation of the data and significance level p<0.05 was accepted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: September 22, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• Elective cesarean section with spinal anesthesia,
• 37 weeks of gestation and above,
• with ASA I and ASA II scores,
• Pregnant women with a healthy fetus,
• The preoperative fasting period is between 2 to 12 hours,
• Pregnant women who were normothermic (36 to 37.5°C) preoperatively

Exclusion Criteria:

• Those requiring emergency delivery or with comorbidities
• Multiple pregnancies,
• Anemic pregnant women with a hemoglobin value below 11 g/dl according to the World Health Organization (2001),
• Central body temperature above 37.5°C and below 36°C on the morning of surgery
• Pregnant women with a history of malnutrition, thyroid function and other endocrine disorders, Parkinson's disease, peripheral circulatory disorders, diabetes mellitus, heart disease and stroke,
• Pregnant women with chronic bowel problems and urinary system problems were not included in the study.

Related Conditions & MeSH terms

• Hypothermia

Intervention

Other:
• Intervention 1 group (underbody heater group only)
Resistive heaters can be set to 38-40°C and are used together with the control unit to which they are connected. In the study, an underbody heater (MEDWARM W 300 IM 190MS branded) system measuring 1900x500x40mm was used. In this study, the underbody heater was set to 38°C for patients. Before use, a surgical drape was placed over it to prevent direct patient contact.
• Intervention 2 group (group using both underbody heater and heated iv liquid)
IV fluids should be warmed to protect patients from unwanted hypothermia during surgery. One liter of saline solution given at room temperature decreases body temperature by 0.25°C in adults. Therefore, the fluids given to the patient should be heated to 33 40°C. In the guideline published by the Turkish Anesthesia Society, it is stated that if more than 1000 2000 mL of fluid is to be given to patients, it should be heated at 37°C (TARD, 2013). In this study, both IV fluids were heated between 37 and 39°C and given to the patient and heated with carbon fiber underbody heaters.
• Control Group
no active heating treatment was applied in this group

Locations

Country	Name	City	State
Turkey	Erciyes Universty	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal well- being	body temperature( degrees cantigrade), intraoperative bleeding (hemoglobin) , shivering(0-10) , postoperative pain (0-10), gas and urination	two day
Secondary	Newborn well- being	body tempereture (degrees cantigrade), APGAR score , cortisol and glucose levels	two day