Maternal Postop Temperature After Cesarean Delivery

Tel Aviv Sourasky Medical Center

Status: Completed

Conditions: Spinal Anesthesia; Temperature Change, Body; Cesarean Delivery

Treatments: Other: Control: Lower body blanket not attached to warm air blower; Device: Warm air blower

Study type: Interventional

Funder types: Other

Identifiers

NCT05661136

CTIL - 0562-22-TLV -

Details and patient eligibility

About

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.

Full 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

Enrollment: 66 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

66 participants in 2 patient groups

Warm air blower

Experimental group

Description:

Intra-operative lower-body forced-air warming after spinal anesthesia and co-loading 1000 mL liters of IV warmed-fluids started prior to performing spinal anesthesia

Treatment:

Device: Warm air blower

Control

Active Comparator group

Description:

Co-loading of 1000 mL liters of IV warmed-fluids started prior to performing spinal anesthesia

Treatment:

Other: Control: Lower body blanket not attached to warm air blower