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Completed

NCT Number: NCT05661136

Maternal Postop Temperature After Cesarean Delivery

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.

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Key information

Conditions

Temperature Change, Body Body Temperature Changes Cesarean Delivery Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Anesthesia

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv SMO

Tel Aviv, Israel

About this study

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

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Known allergy to local anesthetics
  • Contraindication for spinal anesthesia
  • Patient refusal
  • Bleeding diathesis
  • Neuropathy

Treatment and study plan

Warm air blower

Device

Lower body blanket with warm air blower set at 44 deg c started after spinal anesthesia when patient placed in supine/left lat position

Control: Lower body blanket not attached to warm air blower

Other

Control: Lower body blanket placed, not attached to warm air blower

Primary outcomes

  1. The mean core temperature

    Time frame: baseline, immediately before spinal anesthesia, 60 minutes following spinal anesthesia and then every 30 minutes for 2 hours (last measurement prior to discharge)

    The primary aim is the mean core temperature on arrival to PACU. The means for the two groups will be compared.

Secondary outcomes

  1. Maternal hypothermia

    Time frame: 60 minutes following spinal anesthesia

    Maternal hypothermia yes/no defined as core body temperature <36°C

  2. Shivering

    Time frame: Postoperative - every 30 minutes for 2 hours (last measurement prior to discharge)

    Shivering score - 0 - no shivering

    • - One or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis without other cause, but without visible muscular activity
    • - Visible muscular activity confined to one muscle group
    • - Visible muscular activity in more than one muscle group
    • - Gross muscular activity involving the whole body

  3. Maternal thermal comfort

    Time frame: baseline, immediately before spinal anesthesia , 60 minutes following spinal anesthesia, and then every 30 minutes for 2 hours (last measurement prior to discharge)

    Maternal thermal comfort scores (• Thermal comfort scale - a 0 to 10 scale will be used with the descriptors to a single question - "How warm or cold are you?

    o "Worst imaginable cold", " thermally neutral, " and " insufferably hot " representing the 0, 5, and 10 of the scale, respectively) will be obtained at baseline, 30 minutes during surgery, and on admission to PACU

  4. Meperidine

    Time frame: Postoperative - up to two hours during PACU recovery after the procedure

    Meperidine administration (timing and dose) used to treat shivering

  5. Apgar

    Time frame: 1 and 5 minutes after newborn delivery

    Apgar scores (at 1 and 5 minutes) will be determined by the pediatrician (not involved in the study)

  6. Newborn Temperature

    Time frame: Upon newborn's arrival to newborn ward - approximately 30 minutes following delivery

    Newborn rectal temperature

  7. Umbilical vein pH

    Time frame: Immediately following placenta removal intraoperatively

    venous blood gases will be obtained for analysis from a double-clamped segment of umbilical cord

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 22, 2022
Registry last updated
Feb 14, 2025

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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