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CompletedNCT07331168Active warmingUpdated Aug 10, 2026

Evaluation of the Effect of Active Warming Applied to the Mother During Cesarean Section on Post-Breastfeeding Outcomes: A Randomized Controlled Study

An interventional study of active warming and active warming II in Cesarean Resection, Breastfeeding and Thermal Comfort, sponsored by Kutahya Health Sciences University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Cesarean Resection
  • Breastfeeding
  • Thermal Comfort

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Keywords

  • Cesarean
  • active warming
  • thermal comfort
  • breastfeeding
03

In context

Breast Feeding

262 studies on the registry are indexed under Breast Feeding; 112 are open to participants now.

This study's enrollment of 84 is below the median of 95 across 210 interventional studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

Kutahya Health Sciences University is the lead sponsor of 209 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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)

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05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Intervention

    Intervention group

    Other: active warming · Other: active warming II

  • No intervention
    Control

    Control group

Interventions

  • Otheractive warming

    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.

  • Otheractive warming II

    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.

06

What researchers measure

Primary outcomes

  1. Breastfeeding Success

    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.

    Time frame: Postperative Day 1- First breastfeeding session

  2. Breastfeeding success

    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.

    Time frame: Postoperative Day 1, 24.hour

  3. Perception of insufficient milk

    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.

    Time frame: Postoperative Day 1, First breastfeeding session

  4. Perception of insufficient milk

    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.

    Time frame: Postoperative Day 1, 24. hour

  5. Thermal comfort

    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.

    Time frame: Preoperative Day 1, Before the cesarean section

  6. Thermal comfort II

    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.

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

  7. Thermal comfort III

    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.

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

07

Study locations

1 site
  • Kütahya Health Sciences University
    Kütahya, None Selected, Turkey (Türkiye)
08

References and documents

Publications

  • Zhuo Q, Xu JB, Zhang J, Ji B. Effect of active and passive warming on preventing hypothermia and shivering during cesarean delivery: a systematic review and meta-analysis of randomized controlled trials. BMC Pregnancy Childbirth. 2022 Sep 21;22(1):720. doi: 10.1186/s12884-022-05054-7. PubMed 36131231 ↗
  • Yigit F, Cigdem Z, Temizsoy E, Cingi ME, Korel O, Yildirim E, Ovali F. Does warming the breasts affect the amount of breastmilk production? Breastfeed Med. 2012 Dec;7(6):487-8. doi: 10.1089/bfm.2011.0142. Epub 2012 Mar 16. PubMed 22424466 ↗
  • Talhaoglu D, Baser M, Ozgun MT. The Effects of Actively Warming the Patient on Maternal and Infant Well-Being in a Cesarean Section Operation. J Perianesth Nurs. 2024 Jun;39(3):366-374. doi: 10.1016/j.jopan.2023.08.008. Epub 2024 Jan 12. PubMed 38219080 ↗
  • Ozkan H, Uzun Ozer B, Ari O. The Effect of Hot Application Applied to the Breast with the Help of the Thera Pearl in the Postpartum Period on Mothers' Milk Perception and Postpartum Breastfeeding Self-Efficacy: A Randomized Controlled Study. Healthcare (Basel). 2024 May 8;12(10):968. doi: 10.3390/healthcare12100968. PubMed 38786381 ↗
  • Kholeif MFMA, Herpertz GU, Brauer A, Radke OC. Prewarming Parturients for Cesarean Section Does Not Raise Wound Temperature But Body Heat and Level of Comfort: A Randomized Trial. J Perianesth Nurs. 2024 Feb;39(1):58-65. doi: 10.1016/j.jopan.2023.06.001. Epub 2023 Sep 9. PubMed 37690018 ↗
  • Duryea EL, Nelson DB, Wyckoff MH, Grant EN, Tao W, Sadana N, Chalak LF, McIntire DD, Leveno KJ. The impact of ambient operating room temperature on neonatal and maternal hypothermia and associated morbidities: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):505.e1-505.e7. doi: 10.1016/j.ajog.2016.01.190. Epub 2016 Feb 10. PubMed 26874298 ↗
  • Alshakhs FH, Katooa NE, Badr HA, Thabet HA. The Effect of Alternating Application of Cold and Hot Compresses on Reduction of Breast Engorgement Among Lactating Mothers. Cureus. 2024 Jan 28;16(1):e53134. doi: 10.7759/cureus.53134. eCollection 2024 Jan. PubMed 38420104 ↗

Individual participant data

Plan to share: No — It may be shared if contacted by the researcher for reasonable reasons.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07331168
Lead sponsor
Kutahya Health Sciences University
Collaborators
Bilecik Seyh Edebali Universitesi, Kutahya City Hospital
Responsible party
Havva Yeşildere Sağlam (Assistant Professor, Kutahya Health Sciences University) — Principal investigator
First posted
Jan 9, 2026
Start date
Oct 1, 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026
Last update
Aug 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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