Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07331168

EVALUATION OF THE EFFECT OF ACTIVE WARMING APPLIED TO THE MOTHER DURING CESAREAN SECTION ON POST-BREASTFEEDING OUTCOMES: A RANDOMIZED CONTROLLED STUDY

Hypothermia is a complication of cesarean section and a cause of breastfeeding problems. Preventing maternal hypothermia is one of the goals of the enhanced postoperative recovery (ERAS) protocol and is important for the health of both mother and baby. This clinical trial aims to determine the effects of active warming during and after cesarean delivery on breastfeeding outcomes, thermal comfort, and perceived insufficient milk supply.

The primary questions it aims to answer are:

1. To evaluate the effect of active warming during cesarean delivery on mothers' perception of thermal comfort. 2. To evaluate the effect of active warming after cesarean delivery on mothers' perceived insufficient milk supply. 3. To determine the effect of active warming after cesarean delivery on breastfeeding success.

Participants:

Warming will be provided using an active warming bed during cesarean delivery (45 minutes). Warming will continue in the postpartum care unit (45 minutes).

The control group will not receive any warming and will receive the hospital's standard care procedure.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kütahya Health Sciences University

Kütahya, None Selected, Turkey (Türkiye)

Location status: Recruiting

Location contact

Havva Yeşildere Sağlam, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Over 18 years of age
  • Primiparous, singleton pregnancy
  • Gestational age >37 weeks, elective cesarean section under spinal anesthesia
  • No issues with breastfeeding the baby or herself during the postpartum period
  • Voluntarily participating

Exclusion criteria

  • Those with a gestational age of less than 37 weeks,
  • Those with an urgent delivery decision or those with accompanying comorbidities (severe preeclampsia, placenta previa, placental abruption, umbilical cord prolapse, fetal distress),
  • those with multiple pregnancies,
  • those with a core body temperature above 37.5 °C,
  • those who started cesarean delivery with spinal anesthesia and later switched to general anesthesia due to complications,
  • those with known impaired thermoregulation or thyroid disorder

Translated with DeepL.com (free version)

-

Treatment and study plan

active warming

Other

During the cesarean section, heating will be applied at 37 degrees. (45 minutes)

Carbon fiber resistive heating pads are reusable, where a low-voltage electric current flows, causing heat to accumulate in the carbon fibers that make up the blanket's filling. A heating pad will be used to warm participants. This pad has a control unit, is 120 cm long, and is suitable for operating room conditions. It is safe and operates at low voltage. It heats to a maximum of 40 degrees Celsius. In this study, heating will be used to a temperature of 37 degrees Celsius.

active warming II

Other

After the cesarean section, heating will be applied to the recovery area at 37 degrees. (45 minutes)

Carbon fiber resistive heating pads are reusable, where a low-voltage electric current flows, causing heat to accumulate in the carbon fibers that make up the blanket's filling. A heating pad will be used to warm participants. This pad has a control unit, is 120 cm long, and is suitable for operating room conditions. It is safe and operates at low voltage. It heats to a maximum of 40 degrees Celsius. In this study, heating will be used to a temperature of 37 degrees Celsius.

Primary outcomes

  1. Breastfeeding Success

    Time frame: Postperative Day 1- First breastfeeding session

    Evaluation will be performed using the LATCH breastfeeding diagnostic tool. The LATCH Breastfeeding Assessment Scale consists of 5 sub-dimensions: Latch, Audible swallowing, Type of nipple, Comfort, and Hold.

    Each item is scored between 0 and 2 points. The total score ranges from 0 to 10. Higher scores indicate more effective and successful breastfeeding.

  2. Breastfeeding success

    Time frame: Postoperative Day 1, 24.hour

    Evaluation will be performed using the LATCH breastfeeding diagnostic tool. The LATCH Breastfeeding Assessment Scale consists of 5 sub-dimensions: Latch, Audible swallowing, Type of nipple, Comfort, and Hold.

    Each item is scored between 0 and 2 points. The total score ranges from 0 to 10. Higher scores indicate more effective and successful breastfeeding.

  3. Perception of insufficient milk

    Time frame: Postoperative Day 1, First breastfeeding session

    Assessment will be made using the Insufficient Milk Perception Scale. The Perception of Insufficient Milk (PIM) Scale is used to assess mothers' subjective perceptions of whether their milk supply is sufficient to feed their infants. The scale consists of items that question the mother's perception of milk quantity, infant satisfaction, and the adequacy of breastfeeding. Items are generally scored using a Likert scale, and the total score ranges between predetermined minimum and maximum values. Higher scores indicate a higher level of perceived insufficiency in the mother's milk supply. A score of "0" indicates that milk is perceived as completely insufficient, while a score of "10" indicates that milk is perceived as completely sufficient. The scale is scored from 0 to 50. A higher score indicates a higher perception of milk sufficiency.

  4. Perception of insufficient milk

    Time frame: Postoperative Day 1, 24. hour

    The assessment will be performed using the Insufficient Milk Perception Scale. The Perception of Insufficient Milk (PIM) Scale is used to assess mothers' subjective perceptions of whether their milk supply is sufficient to feed their infants. The scale consists of items that question the mother's perception of milk quantity, infant satisfaction, and the adequacy of breastfeeding. Items are generally scored using a Likert scale, and the total score ranges between predetermined minimum and maximum values. Higher scores indicate a higher level of perceived insufficiency in the mother's milk supply. A score of "0" indicates that milk is perceived as completely insufficient, while a score of "10" indicates that milk is perceived as completely sufficient. The scale is scored from 0 to 50. A higher score indicates a higher perception of milk sufficiency.

  5. Thermal comfort

    Time frame: Preoperative Day 1, Before the cesarean section

    The Thermal Comfort Perception Scale will be used. The Thermal Comfort Scale is a subjective scale used to assess how comfortable, acceptable, or uncomfortable individuals perceive the temperature conditions of their environment. The scale is generally a single-item or multi-item structure that questions the perception of hot-cold and the level of thermal comfort. Scores range between predetermined minimum and maximum values, with higher scores indicating a higher level of thermal comfort and lower scores indicating thermal discomfort. The scale is a 5-point Likert type with options of 1 "none", 2 "somewhat", 3 "moderately", 4 "a lot", and 5 "very much". The lowest possible score on the 11-item scale is 11, and the highest is 49.

  6. Thermal comfort II

    Time frame: Day 1, During the cesarean section (at 15 minutes)

    The Temperature Comfort Perception Scale will be used. The Thermal Comfort Perception Scale will be used. The Thermal Comfort Scale is a subjective scale used to assess how comfortable, acceptable, or uncomfortable individuals perceive the temperature conditions of their environment. The scale is generally a single-item or multi-item structure that questions the perception of hot-cold and the level of thermal comfort. Scores range between predetermined minimum and maximum values, with higher scores indicating a higher level of thermal comfort and lower scores indicating thermal discomfort. The scale is a 5-point Likert type with options of 1 "none", 2 "somewhat", 3 "moderately", 4 "a lot", and 5 "very much". The lowest possible score on the 11-item scale is 11, and the highest is 49.

  7. Thermal comfort III

    Time frame: Postoperative Day 1,After the cesarean section (at 30 minutes)

    The Thermal Comfort Perception Scale will be used. The Thermal Comfort Scale is a subjective scale used to assess how comfortable, acceptable, or uncomfortable individuals perceive the temperature conditions of their environment. The scale is generally a single-item or multi-item structure that questions the perception of hot-cold and the level of thermal comfort. Scores range between predetermined minimum and maximum values, with higher scores indicating a higher level of thermal comfort and lower scores indicating thermal discomfort. The scale is a 5-point Likert type with options of 1 "none", 2 "somewhat", 3 "moderately", 4 "a lot", and 5 "very much". The lowest possible score on the 11-item scale is 11, and the highest is 49.

Study contacts

Contact information is provided by the study sponsor or research team.

Havva Yeşildere Sağlam, PhD

CONTACT

[email protected]

0 (274) 260 00 43

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Collaborators

  • Bilecik Seyh Edebali Universitesi
  • Kutahya City Hospital

Registry information

Acronym: ACTIVE WARMING

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

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.

Published trials that share one or more normalized conditions with this study.