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

Обзор

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.

Вмешательства

• Другое active 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,
• Другое active 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 Cel

Первичные конечные точки

• Breastfeeding Success [Срок оценки: Postperative Day 1- First breastfeeding session]
• Breastfeeding success [Срок оценки: Postoperative Day 1, 24.hour]
• Perception of insufficient milk [Срок оценки: Postoperative Day 1, First breastfeeding session]
• Perception of insufficient milk [Срок оценки: Postoperative Day 1, 24. hour]
• Thermal comfort [Срок оценки: Preoperative Day 1, Before the cesarean section]
• Thermal comfort II [Срок оценки: Day 1, During the cesarean section (at 15 minutes)]
• Thermal comfort III [Срок оценки: Postoperative Day 1,After the cesarean section (at 30 minutes)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Kütahya Health Sciences University — Kütahya

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 38420104

Идентификаторы

NCT: NCT07331168 · KutahyaHSU_2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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