Status:
NOT_YET_RECRUITING
Effect of Maintenance of Intraoperative Normothermia in Cesarean Section on Thermal Comfort, Serum Cortisol and Apgar Score: A Randomized Controlled Trial
Lead Sponsor:
Kocaeli University
Conditions:
Pregnancy
Eligibility:
FEMALE
19-39 years
Phase:
NA
Brief Summary
Cesarean section is a common method of delivery worldwide today. According to WHO, cesarean section accounts for more than 1 in 5 (21%) of all births, and it is predicted that approximately one-third ...
Eligibility Criteria
Inclusion
- • Being 19 years of age or older pregnant
- Being at least a primary school graduate
- Having an elective cesarean section with spinal/epidural anesthesia
- Being at or above the 38th week of pregnancy
- Being in the ASA I (Normal, healthy person with no disease or systemic problem other than surgical pathology that does not cause a systemic disorder) class
- Not being diagnosed with high-risk pregnancy (such as oligodydroamnios, premature membrane rupture, gestational diabetes mellitus, preeclampsia, fetal tachycardia, nonreactive NST, intrauterine growth retardation)
- Having a body mass index of \>19 kg/m2 and \<40 kg/m2
- Having a singleton pregnancy
- Having a healthy fetus
- Having a fasting period of 2-6 hours before surgery
- Being normothermic (36-37.5°C) (tympanic measurement) before surgery
Exclusion
- •Having comorbidities that require emergency delivery or accompany it (severe preeclampsia, bleeding placenta previa, abruption placenta, cord prolapse, fetal distress)
- Need for intensive care in the mother or newborn after cesarean section
- Being anemic with a hemoglobin value below 10 g/dl according to the World Health Organization (2001)
- Not having platelet values within the reference values
- Having any disease that will disrupt the bleeding clotting mechanism (hemophilia, liver failure, vitamin K deficiency, etc.)
- Having a body core temperature above 37.5°C and below 36°C on the morning of surgery
- Having malnutrition, thyroid function and other endocrine disorders, Parkinson's, peripheral circulatory disorders, Diabetes Mellitus, heart disease and a history of stroke
- Having any deterioration on the skin surface of the arms and legs (ecchymosis, edema, urticaria, etc.)
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06962241
Start Date
June 1 2025
End Date
July 1 2026
Last Update
May 8 2025
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