Impact of Active Heating on Maternal and Neonatal Well-being

NCT06259942 | Completed

• 1 other identifier: Surgery-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hypothermia

Outcome Measures

Primary Outcomes (1)

• Maternal well- being

  body temperature( degrees cantigrade), intraoperative bleeding (hemoglobin) , shivering(0-10) , postoperative pain (0-10), gas and urination

  two day

Secondary Outcomes (1)

• Newborn well- being

  two day

Study Arms (3)

Intervention 1 group

EXPERIMENTAL

only the group heated throughout surgery with carbon fiber underbody heaters

Other: İntervention 1 group (underbody heater group only); Other: Control Group

Intervention 2 group

ACTIVE COMPARATOR

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)

Control group

NO INTERVENTION

routine practice of the hospital where the surgery was performed (no heater applied group)

Interventions

İntervention 1 group (underbody heater group only) OTHER

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.

Also known as: MEDWARM W-300 IM-190MS

Intervention 1 group

İntervention 2 group (group using both underbody heater and heated iv liquid) OTHER

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.

Also known as: MEDWARM W-300 IM-190MS, QW3 Blood and Serum Warmer

Intervention 2 group

Control Group OTHER

no active heating treatment was applied in this group

Also known as: group without active heating

Intervention 1 group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Elective cesarean section with spinal anesthesia,
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes Unıversty

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Control Groups; Population Groups

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Demography; Population Characteristics

Study Officials

• Dilek TALHAOĞLU, PhD

  She was a doctoral student at Erciyes University, Institute of Health Sciences.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: women undergoing elective caesarean section
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 14, 2024
• Study Start: June 19, 2022
• Primary Completion: September 20, 2022
• Study Completion: September 22, 2022
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)