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临床试验/NCT07331168
NCT07331168
招募中
不适用

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

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年10月1日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Kutahya Health Sciences University
入组人数
68
试验地点
1
主要终点
Breastfeeding Success

概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Intervention

Experimental

Active warming group

干预措施: active warming (Other)

Intervention

Experimental

Active warming group

干预措施: active warming II (Other)

Control

No Intervention

Control group

结局指标

主要结局

Breastfeeding Success

时间窗: 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.

Breastfeeding success

时间窗: 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.

Perception of insufficient milk

时间窗: 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.

Thermal comfort

时间窗: 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.

Thermal comfort II

时间窗: 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.

Thermal comfort III

时间窗: 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.

Perception of insufficient milk

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Havva Yeşildere Sağlam

Assistant Professor

Kutahya Health Sciences University

研究点 (1)

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