Impact of Active Heating on Maternal and Neonatal Well-being

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

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

Study Overview

• Status: Completed
• Conditions: Hypothermia
• Intervention / Treatment: Other: İntervention 1 group (underbody heater group only); Other: Control Group; Other: İntervention 2 group (group using both underbody heater and heated iv liquid)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey
    • Erciyes Unıversty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention 1 group; only the group heated throughout surgery with carbon fiber underbody heaters	Other: İntervention 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.; Other Names: MEDWARM W-300 IM-190MS; Other: Control Group; no active heating treatment was applied in this group; Other Names: group without active heating
Active Comparator: Intervention 2 group; the group that was both warmed throughout the operation with carbon fiber underbody heaters and given warmed intravenous fluids	Other: İntervention 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.; Other Names: MEDWARM W-300 IM-190MS, QW3 Blood and Serum Warmer
No Intervention: Control group; routine practice of the hospital where the surgery was performed (no heater applied group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal well- being	body temperature( degrees cantigrade), intraoperative bleeding (hemoglobin) , shivering(0-10) , postoperative pain (0-10), gas and urination	two day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn well- being	body tempereture (degrees cantigrade), APGAR score , cortisol and glucose levels	two day

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: Dilek TALHAOĞLU, PhD, She was a doctoral student at Erciyes University, Institute of Health Sciences.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2022
• Primary Completion (Actual): September 20, 2022
• Study Completion (Actual): September 22, 2022

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Estimated): February 14, 2024

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: Surgery-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: December 2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No