Effect of Maintenance of Intraoperative Normothermia in Cesarean Section on Thermal Comfort, Serum Cortisol and Apgar Score: A Randomized Controlled Trial

ConditionPregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-39
SponsorKocaeli University

About this trial

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 (29%) of births will be by cesarean section by 2030. Although cesarean section is a vital and life-saving surgery, it can unnecessarily put mothers and babies at risk for short- and long-term health problems when performed without a medical necessity. Unintended perioperative hypothermia, defined as the inadvertent lowering of core temperature below 36°C during surgery, is a well-known complication of anesthesia. Hypothermia can increase the risk of infection by suppressing the immune system, prolonging the recovery process, and triggering postpartum complications. Maintaining maternal body temperature during cesarean section helps reduce postoperative complications, reduce the risk of infection, and accelerate the recovery process. It is also critical for the health of the baby. Keeping the newborn's body temperature stable can help minimize risks such as hypoxia at birth. However, there are increasing studies showing that temperature control is not only limited to maternal health but also has serious effects on the baby after birth. Therefore, it is understood that maintaining body temperature during cesarean section is an important factor in improving the quality of life for both individuals. This article aims to deeply examine the role of temperature control during cesarean section on maternal and fetal health and the benefits of this intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Warming group

    Other intervention

    When the pregnant women in the experimental group were laid on the operating table, they were heated from the back with a heating pad. The heating pad remained on the pregnant woman's back throughout the cesarean section. The cesarean section took an average of 35 minutes from the first surgical incision to the completion of the incision after spinal/epidural anesthesia.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Warming groupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Concerns of pregnant women who are warmed by a heating pad

Anxiety of pregnant women warmed with a heating pad will be measured with the Trait Anxiety Inventory (STAI). It is indicated by selecting one of the following options: "(1) None, (2) A Little, (3) A Lot and (4) Completely".

Time frame
Questions will be asked half an hour before the caesarean section

Secondary outcomes

1

Thermal Comfort of Pregnant Women Warmed with a Heating Pad

The Thermal Comfort scale will be used to measure the pregnant women's comfort after the Caesarean section, which was warmed with a heating pad.

Time frame
will be measured half an hour after the cesarean section

Other outcomes

1

The effect of warming pregnant women with a heating pad on the Apgar scores of their babies

Time frame
The Apgar score of the baby born after cesarean section will be evaluated at the 1st and 5th minutes.
2

Effect of heating pad on shivering of pregnant women

The heating pad will be measured with the shivering scale in pregnant women. Zero means no shake, while 3 means the worst possible shake.

Time frame
will be measured half an hour before and half an hour after the caesarean section
3

warming affects serum cortisol level of newborns

Time frame
After birth, blood will be taken from the umbilical cord and serum cortisol levels will be checked.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: