Impact of Active Heating on Maternal and Neonatal Well-being

Not Applicable

Completed

• Conditions: Hypothermia
• Interventions: Other: İntervention 2 group (group using both underbody heater and heated iv liquid); Other: İntervention 1 group (underbody heater group only); Other: Control Group

• Registration Number: NCT06259942
• Lead Sponsor: TC Erciyes University

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

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 Timeline

• Study Start: 2022-06-19
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-22
• Study First Submitted: 2024-01-12
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention 1 group	Control Group	only the group heated throughout surgery with carbon fiber underbody heaters
Intervention 2 group	İntervention 2 group (group using both underbody heater and heated iv liquid)	the group that was both warmed throughout the operation with carbon fiber underbody heaters and given warmed intravenous fluids
Intervention 1 group	İntervention 1 group (underbody heater group only)	only the group heated throughout surgery with carbon fiber underbody heaters

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Newborn well- being	two day	body tempereture (degrees cantigrade), APGAR score , cortisol and glucose levels

Trial Locations

Locations (1)

Erciyes Unıversty; 🇹🇷 Kayseri, Turkey