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Completed

NCT Number: NCT06259942

Impact of Active Heating on Maternal and Neonatal Well-being

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

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Key information

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes Unıversty

Kayseri, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: MEDWARM W-300 IM-190MS

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.

Other names: MEDWARM W-300 IM-190MS, QW3 Blood and Serum Warmer

Control Group

Other

no active heating treatment was applied in this group

Other names: group without active heating

Primary outcomes

  1. Maternal well- being

    Time frame: two day

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

Secondary outcomes

  1. Newborn well- being

    Time frame: two day

    body tempereture (degrees cantigrade), APGAR score , cortisol and glucose levels

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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