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Impact of Active Heating on Maternal and Neonatal Well-being

T

TC Erciyes University

Status

Completed

Conditions

Hypothermia

Treatments

Other: Control Group
Other: İntervention 2 group (group using both underbody heater and heated iv liquid)
Other: İntervention 1 group (underbody heater group only)

Study type

Interventional

Funder types

Other

Identifiers

NCT06259942
Surgery-01

Details and patient eligibility

About

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

Full 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.

Enrollment

105 patients

Sex

Female

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

105 participants in 3 patient groups

Intervention 1 group
Experimental group
Description:
only the group heated throughout surgery with carbon fiber underbody heaters
Treatment:
Other: İntervention 1 group (underbody heater group only)
Other: Control Group
Intervention 2 group
Active Comparator group
Description:
the group that was both warmed throughout the operation with carbon fiber underbody heaters and given warmed intravenous fluids
Treatment:
Other: İntervention 2 group (group using both underbody heater and heated iv liquid)
Control group
No Intervention group
Description:
routine practice of the hospital where the surgery was performed (no heater applied group)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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