Clinical trial NCT05661136: Maternal Postop Temperature After Cesarean Delivery
Official title: Maternal Postoperative Temperature After Cesarean Delivery Under Spinal Anesthesia With Warmed Intravenous Fluids: Randomized Controlled Trial With Versus Without Lower Body Forced Air Warming
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temperature Change, Body
Cesarean Delivery
Spinal Anesthesia
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-12-22
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two arms: lower body forced air warming versus none
Primary purpose: OTHER

Brief 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.

Detailed description: Primary aim Investigate whether a combination of intra-operative lower-body forced-air warming and warmed IV fluids is superior to our current standard of warmed IV fluids alone in influencing maternal core temperature following spinal anesthesia for cesarean delivery.

Secondary aim

1. To compare mean core temperature on arrival to post-anesthesia care unit (PACU) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
2. To compare incidence of hypothermia among women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
3. To compare incidence of shivering following recovery in post anesthesia care unit (PACU) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
4. To compare thermal comfort levels for women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
5. To compare use of meperidine in post anesthesia care unit (PACU) to treat postoperative shivering, in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
6. To compare newborn outcomes (rectal temperature at birth, umbilical vein pH \& Apgar scores post-delivery) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone

Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. Age between 18-50 years old
3. American Society of Anesthesiologists (ASA) physical status 2-3
4. Gestational age greater than 37 completed weeks
5. Singleton pregnancy
6. Elective cesarean delivery.

Exclusion Criteria:

1. Known allergy to local anesthetics
2. Contraindication for spinal anesthesia

   1. Patient refusal
   2. Bleeding diathesis
   3. Neuropathy

Primary outcomes:
measure: The mean core temperature
timeFrame: baseline, immediately before spinal anesthesia, 60 minutes following spinal anesthesia and then every 30 minutes for 2 hours (last measurement prior to discharge)
Secondary outcomes:
measure: Maternal hypothermia
timeFrame: 60 minutes following spinal anesthesia
measure: Shivering
timeFrame: Postoperative - every 30 minutes for 2 hours (last measurement prior to discharge)
measure: Maternal thermal comfort
timeFrame: baseline, immediately before spinal anesthesia , 60 minutes following spinal anesthesia, and then every 30 minutes for 2 hours (last measurement prior to discharge)
measure: Meperidine
timeFrame: Postoperative - up to two hours during PACU recovery after the procedure
measure: Apgar
timeFrame: 1 and 5 minutes after newborn delivery
measure: Newborn Temperature
timeFrame: Upon newborn's arrival to newborn ward - approximately 30 minutes following delivery
measure: Umbilical vein pH
timeFrame: Immediately following placenta removal intraoperatively
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv SMO
Study officials:
References: