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Cesarean ResectionActive warmingNCT07331168

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

A study testing active warming and active warming II in people with Cesarean Resection and Breastfeeding, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cesarean Resection, Breastfeeding, Thermal Comfort
What is being tested?
active warming and active warming II
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2025to 31 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
  • -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kütahya Health Sciences University

    Kütahya, None Selected

Other trials in Turkey (Türkiye)

About this 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:

Read more
  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.

Being tested
active warming, active warming II
Keywords
Cesarean, active warming, thermal comfort, breastfeeding
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • active warmingOther

    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 IIOther

    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.

Study groups in NCT07331168
Study groupRoleWhat they receive
InterventionExperimentalIntervention group
Receives: Other: active warming; Other: active warming II
ControlNo interventionControl group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2026
  2. Study start1 Oct 2025
  3. Primary completion31 Mar 2026
  4. Study completion31 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, controlled, parallel-group interventional study evaluating the effect of active warming applied to mothers during and after cesarean delivery on early postpartum breastfeeding outcomes. Participants will be randomly assigned, via computer-generated allocation, to either the intervention group receiving active warming or the control group receiving standard care without warming. The study will be conducted in a \[single-blind / open-label\] manner. The primary objective is to assess the effect of active warming on breastfeeding success, thermal comfort, and perceived insufficient milk supply.
Masking
Single blind
Who is masked
Participant
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07331168
Sponsor's protocol ID
KutahyaHSU_2025
Acronym
Active warming
Status last verified
Aug 2026
First submitted
17 Nov 2025
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It may be shared if contacted by the researcher for reasonable reasons.

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

Questions about this trial

What is this clinical trial studying?

A study testing active warming and active warming II in people with Cesarean Resection and Breastfeeding, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breastfeeding Success (time frame: Postperative Day 1- First breastfeeding session). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07331168, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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