Immediate Skin-to-Skin Contact and Breastfeeding During Caesarean Section: A Randomized Controlled Trial on Early Neonatal Hypoglycemia in Late Preterm and Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Incidence of neonatal hypoglycemia
研究概览
简要总结
Background: Neonatal hypoglycemia is a prevalent and serious condition among late preterm and term infants, which can lead to severe neurodevelopmental consequences if not managed properly. Immediate skin-to-skin contact (SSC) and early initiation of breastfeeding are recognized as effective interventions to stabilize glucose levels and support neonatal adaptation to extrauterine life. However, implementing these practices during cesarean sections (CS) presents challenges due to the need to maintain a sterile surgical environment and logistical complexities.
Objective: This study aims to evaluate the effects of immediate SSC and early breastfeeding initiation during CS on neonatal hypoglycemia and breastfeeding outcomes.
Methods: A randomized controlled trial was conducted with 336 mother-neonate pairs undergoing elective CS. Participants were randomly assigned to either the experimental group, which received immediate SSC and early breastfeeding during CS, or the control group, which received standard care. Blood glucose levels of neonates were monitored at 1, 3, and 6 hours post-birth. Additional outcomes included the time to breastfeeding initiation, duration of the first breastfeeding session, onset of lactogenesis II, and the rate of exclusive breastfeeding during hospitalization.
详细描述
Neonatal hypoglycemia is a common condition among late preterm and term infants. It can lead to severe neurodevelopmental consequences if not managed properly. Immediate skin-to-skin contact (SSC) and early initiation of breastfeeding are effective interventions for stabilizing glucose levels and supporting neonatal adaptation to extrauterine life. While these practices are well-documented for their benefits in vaginal births, their implementation during cesarean sections (CS) presents challenges due to the need for maintaining a sterile surgical environment and the logistical complexities involved. The primary objective of this study was to evaluate the effects of immediate SSC and early breastfeeding initiation during CS on neonatal hypoglycemia and breastfeeding outcomes in late preterm and term infants.
This study was designed as a pragmatic, parallel-design, two-arm randomized controlled trial. It was conducted at Qingdao Municipal Hospital in China from July 2023 to July 2024. A total of 336 eligible mother-neonate pairs undergoing elective CS were included in the study.
Participants included mothers aged 18 years or older with a singleton pregnancy and gestational age between 34+1 and 41+6 weeks, undergoing elective CS with epidural or spinal anesthesia, willing to engage in SSC and breastfeeding during and after surgery, and newborns with Apgar scores above 8 at 1 and 5 minutes, a strong sucking reflex, and no critical conditions requiring transfer. Exclusion criteria involved serious pregnancy complications (e.g., placenta previa, eclampsia), conditions hindering SSC initiation (e.g., neonatal asphyxia, maternal excessive bleeding), and previous breast surgeries or medications affecting breastfeeding.
Participants were randomly assigned to either the experimental group (immediate SSC and early breastfeeding during CS) or the control group (standard care) using a block randomization sequence generated by Microsoft Excel 2010. The randomization process was centrally managed, with blinding maintained for staff performing SSC and data collectors, though patient blinding was not feasible.
Interventions:
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mothers aged 18 years or older with a singleton pregnancy, gestational age between 34+1 and 41+6 weeks.
- •undergoing elective cesarean section with epidural, subarachnoid block, or combined spinal-epidural anesthesia, willing to engage in mother-infant SSC during and after the surgery, without experiencing severe reactions to anesthesia like vomiting or shivering that could affect SSC.
- •having intention to breastfeed with no major contraindications (e.g., hepatitis B, syphilis, HIV, or other infectious diseases).
- •newborns with Apgar scores above 8 at 1 and 5 minutes, a strong sucking reflex, and no critical neonatal conditions requiring transfer.
排除标准
- •serious pregnancy complications such as placenta previa, placenta accreta spectrum, eclampsia, and grade 3 or higher cardiac issues per NYHA standards.
- •challenges in initiating mother-infant SSC include emergencies such as neonatal asphyxia or respiratory distress, maternal excessive bleeding during surgery, and maternal infectious dermatoses.
- •previous breast surgeries such as biopsies or augmentations, nipple inversions complicating breastfeeding, or taking medications affecting lactation.
结局指标
主要结局
Incidence of neonatal hypoglycemia
时间窗: 1, 3, and 6 hours after birth
Neonatal blood glucose levels were assessed using the Stat Strip Xpress glucose meter at 1, 3, and 6 hours after birth. Hypoglycemia was categorized as follows: mild hypoglycemia (overall) at \<45 mg/dL, moderate-to-severe at \<36 mg/dL, and severe at \<18 mg/dL. Treatment was initiated if levels dropped below 25 mg/dL or if symptoms like shakiness, tachycardia, pallor, hypothermia, hunger, sweating, or weakness appeared. In such cases, 10 ml/kg of formula was administered, followed by a recheck after 0.5 hour. If levels rise above 40 mg/dL, subsequent checks occurred every 3 hours. Persistent levels below 50 mg/dL necessitated continued formula feeding and monitoring, or transferred to neonatal care if needed.
次要结局
- Exclusive breastfeeding rate during hospitalization(The assessment occurs from delivery to pre-discharge, an average of 5 days.)
- Duration of first breastfeeding(Assessment occurs immediately post-operation, with timing recorded to the minute.)
- Onset of lactogenesis II(The assessment occurs from surgery to pre-discharge, with timing recorded to the hour postpartum, an average of 72 hours.)
- Breastfeeding initiation time(Assessment occurs immediately post-operation, with timing recorded to the minute.)
研究者
Jia Qiao
RN
Qingdao Municipal Hospital