Clinical trial NCT06259942: Impact of Active Heating on Maternal and Neonatal Well-being
Official title: The Effect of Usıng Heated Intravenous Fluıds wıth Underbody Warmers on Maternal and Neonatal Well-Beıng in Cesarean Sectıon Operatıons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 105
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maternal well- being
timeFrame: two day
Secondary outcomes:
measure: Newborn well- being
timeFrame: two day
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes Unıversty
Study officials:
affiliation: She was a doctoral student at Erciyes University, Institute of Health Sciences.
name: Dilek TALHAOĞLU, PhD
role: PRINCIPAL_INVESTIGATOR
References: