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Recruiting
NCT05661136
Maternal Postop Temperature After Cesarean Delivery
Conditions: Temperature Change, Body, Cesarean Delivery, Spinal Anesthesia
Sex: Female
Ages: 18 Years – 50 Years
Phase: NA
Enrollment: 66
Sponsor: Tel-Aviv Sourasky Medical Center
Location: Israel
Summary
It is unclear whether routine addition of intra-operative forced-air warming in addition to warmed intravenous fluids during cesarean delivery under spinal anesthesia is beneficial.
In this single-center randomized trial, we aim to test the primary null hypothesis that our current protocol of warmed intravenous fluids is similar to a combination of warmed intravenous fluids with intra-operative lower-body forced-air warming to maintain maternal temperature after cesarean delivery under spinal anesthesia.We also aim to assess the rate of maternal shivering during and after the procedure between the two groups, the maternal thermal comfort score, neonatal Apgar scores and umbilical pH levels.
If we demonstrate no clinically important difference between the two interventions, clinicians will be able to continue our current protocol of warmed intravenous fluids only during cesarean delivery.
Eligibility Criteria
Inclusion Criteria:Written informed consentAge between 18-50 years oldAmerican Society of Anesthesiologists (ASA) physical status 2-3Gestational age greater than 37 completed weeksSingleton pregnancyElective cesarean delivery.Exclusion Criteria:Known allergy to local anestheticsContraindication for spinal anesthesiaPatient refusalBleeding diathesisNeuropathy
Source: ClinicalTrials.gov (NCT05661136). StuddyBuddy aggregates publicly available trial information.