Immediate Skin-To-Skin Contact and Early Breastfeeding During Caesarean Section
NCT Number: NCT06543160
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neonatal Hypoglycemia
Interventions: OTHER: Immediate SSC and early breastfeeding during CS|OTHER: Delayed SSC and breastfeeding after CS|OTHER: Routine newborn care
Sponsor: Qingdao Municipal Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 336
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-07-01
Completion Date: 2024-07-20
Locations: Qingdao Municipal Hospital, Qingdao, Shandong, 266000, China

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.

Primary Outcome Measures: Incidence of neonatal hypoglycemia, 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., 1, 3, and 6 hours after birth
Secondary Outcome Measures: Breastfeeding initiation time, Characterized by newborns correctly latching onto the nipple and areola, and establishing regular, effective sucking and swallowing., Assessment occurs immediately post-operation, with timing recorded to the minute.|Duration of first breastfeeding, Start Timing at Latch-On: Begin timing when the infant first latches onto the breast.

End Timing at Detachment: Stop timing when the infant detaches from the breast, either naturally or with assistance from the mother or healthcare provider., Assessment occurs immediately post-operation, with timing recorded to the minute.|Onset of lactogenesis II, Marked by significant milk secretion perceived by the mother as breast fullness, confirmed by observing and squeezing the areola to assess milk spillage., The assessment occurs from surgery to pre-discharge, with timing recorded to the hour postpartum, an average of 72 hours.|Exclusive breastfeeding rate during hospitalization, This rate was calculated for mothers who underwent cesarean delivery in both study groups., The assessment occurs from delivery to pre-discharge, an average of 5 days.