Immediate Skin-To-Skin Contact and Early Breastfeeding During Caesarean Section
NCT06543160 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 336
Last updated 2024-08-07
Summary
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.
Conditions
- Neonatal Hypoglycemia
Interventions
- OTHER
-
Immediate SSC and early breastfeeding during CS
Upon birth, the neonate is promptly placed prone on the mother's chest, with their head turned to one side for optimal skin contact. The drying process begins within 5 seconds and is completed within 20 to 30 seconds while the neonate remains on the mother's chest. Delayed cord clamping is practiced, with the cord clamped approximately 1-3 minutes after birth. Breastfeeding cues such as tongue movements or head turning are monitored, and the obstetric nurse assists the mother in initiating breastfeeding as soon as possible. SSC continues throughout the cesarean procedure, and upon completion, the newborn is temporarily separated from the mother for safety during transfer to the surgical cart. SSC is resumed immediately post-transfer and continues for a cumulative duration of at least 90 minutes. The neonate's skin color, breathing, and feeding responses are continuously observed.
- OTHER
-
Delayed SSC and breastfeeding after CS
The neonate is dried within 20-30 seconds after birth, the cord is clamped after 1-3 minutes, and then the neonate is sent to the ward to wait for the mother to complete the surgery. Immediate SSC is initiated within one hour after birth and maintained with the mother for at least 90 minutes post-surgery, during which the neonate's skin color and breathing are continuously monitored. The obstetric nurse supports the mother in initiating breastfeeding at the earliest opportunity.
- OTHER
-
Routine newborn care
Newborn eye care, vitamin K1 administration, immunizations, weighing, and standard examinations are conducted before the neonate is transferred to the ward.
Sponsors & Collaborators
-
Qingdao Municipal Hospital
lead OTHER
Principal Investigators
-
Jia Qiao · Qingdao Municipal Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-07-01
- Primary Completion
- 2024-05-15
- Completion
- 2024-07-20
Countries
- China
Study Locations
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