Immediate Skin-to-Skin Contact and Breastfeeding During Caesarean Section: A Randomized Controlled Trial on Early Neonatal Hypoglycemia in Late Preterm and Term Infants
Phase: NA
Conditions: Neonatal Hypoglycemia
Sponsor: Qingdao Municipal Hospital

IMMEDIATE SKIN-TO-SKIN CONTACT DURING CAESAREAN SECTION 
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Immediate Skin-to-Skin Contact and Breastfeeding During Caesarean Section: A 
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Randomized Controlled Trial on Early Neonatal Hypoglycemia in Late Preterm 
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and Term Infants 
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1. Introduction 
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Neonatal hypoglycemia is a common and serious metabolic issue in late preterm 
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and term infants, potentially leading to severe neurodevelopmental sequelae if not 
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promptly managed1. The World Health Organization strongly endorses skin-to-skin 
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contact (SSC), recommending that the practice should begin immediately after birth by 
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placing the naked infant on the mother’s bare chest. This approach is vital for stabilizing 
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glucose levels and supporting neonatal adaptation to extrauterine life2. 
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Despite the well-documented advantages of SSC in vaginal births, such as thermal 
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regulation, breastfeeding initiation, and bonding, implementing this practice during 
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cesarean sections (CS) presents significant challenges3. These challenges primarily 
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stem from the need to maintain a sterile surgical environment and the logistical 
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complexities of performing SSC immediately post-surgery4. However, research 
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indicates that immediate, continuous SSC within 5–10 minutes of neonatal delivery 
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during and after CS can foster earlier breastfeeding initiation, increase breastfeeding 
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self-efficacy and exclusive breastfeeding rates during hospitalization, and enhance 
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maternal satisfaction5. Additionally, it can reduce the incidence of neonatal 
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hypothermia and cumulative blood loss within 24 hours postpartum. 
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Despite the advantages noted in the literature, there is limited systematic research 
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on the implementation of SSC during CS and its specific impact on neonatal 
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hypoglycemia and breastfeeding outcomes4. This study aimed to address this gap by 
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evaluating the effects of immediate SSC and breastfeeding during CS on early neonatal 
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hypoglycemia in late preterm and term infants. Through a randomized controlled trial, 
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we sought to provide robust evidence on the feasibility and benefits of integrating these 
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practices into standard CS protocols. Our findings could inform clinical guidelines, 
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enhance care practices for cesarean deliveries, and ultimately improve neonatal health 
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outcomes and breastfeeding success. 
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IMMEDIATE SKIN-TO-SKIN CONTACT DURING CAESAREAN SECTION 
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2. Material and Methods 
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2.1 Study Design 
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This study will adopt a pragmatic, parallel-design, two-arm randomized 
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controlled exploratory framework. The article’s reporting will adhere to the 
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Consolidated Standards of Reporting Trials (CONSORT) guidelines6.  
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2.2 Study Setting, Recruitment and Ethics 
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This study will be conducted at Qingdao Municipal Hospital in China between 
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July 2022 and June 2024. The hospital is accredited as baby-friendly and adheres to 
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the Ten Steps to Successful Breastfeeding as outlined by the Baby-Friendly Hospital 
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Initiative (BFHI) by UNICEF and WHO7. A total of 344 eligible mother-neonate pairs 
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will be recruited and allocated into the experimental group (EG) and control group 
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(CG) at a 1:1 ratio. Written informed consent will be obtained from each participant. 
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2.3 Inclusion Criteria 
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Inclusion criteria are as follows: (a) mothers aged 18 years or older with a 
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singleton pregnancy, gestational age between 34+1 and 41+6 weeks; (b) undergoing 
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elective cesarean section with epidural, subarachnoid block, or combined spinal-
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epidural anesthesia, willing to engage in mother-infant SSC during and after the 
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surgery, without experiencing severe reactions to anesthesia like vomiting or 
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shivering that could affect SSC; (c) having intention to breastfeed with no major 
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contraindications (e.g., hepatitis B, syphilis, HIV, or other infectious diseases); (d) 
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newborns with Apgar scores above 8 at 1 and 5 minutes, a strong sucking reflex, and 
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no critical neonatal conditions requiring transfer. 
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2.4 Exclusion criteria 
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Exclusion criteria are as follows: (a) serious pregnancy complications such as 
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placenta previa, placenta accreta spectrum, eclampsia, and grade 3 or higher cardiac 
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issues per NYHA standards; (b) challenges in initiating mother-infant SSC include 
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emergencies such as neonatal asphyxia or respiratory distress, maternal excessive 
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bleeding during surgery, and maternal infectious dermatoses; (c) previous breast 
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IMMEDIATE SKIN-TO-SKIN CONTACT DURING CAESAREAN SECTION 
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surgeries such as biopsies or augmentations, nipple inversions complicating 
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breastfeeding, or taking medications affecting lactation. 
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2.5 Randomization and Blinding 
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A randomization sequence will be generated using Microsoft Excel 2010 with 
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block randomization in blocks of four via a central system. Random distribution cards 
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will be placed in numbered opaque envelopes, each corresponding to a card. As 
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eligible participants enrolled, envelopes will be opened sequentially to assign 
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treatments based on predetermined groupings. The randomization plan will be 
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designed by a public health graduate student specializing in medical statistics, who 
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will not be involved in the clinical phase. Staff performing SSC during and after 
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cesarean will be blinded to the randomization procedure, and data collectors and 
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statistical analysts will be unaware of patient groupings. However, blinding of patients 
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will not be feasible. 
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2.6 Experimental Group (EG) 
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2.6.1 Administration of SSC and BF during CS  
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A multidisciplinary team, including obstetricians, pediatricians, anesthetists, 
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nursing staff, and other personnel, collaborates to implement a SSC and BF during CS 
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(skin-to-skin contact and breastfeeding during cesarean section) protocol for the 
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intervention. Following spinal anesthesia, the gynecologist initiates surgery with double 
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sterile gloves and arm sleeves. The pediatrician remains on standby in the adjacent 
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neonatal resuscitation room to manage any distress in the newborn. As the neonate is 
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delivered, the surgical drape is lowered, allowing the parents to witness the birth. The 
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neonate, facing the parents, is gently placed on the mother's chest by an obstetric nurse. 
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Before resuming the procedure, the surgeon removes one pair of gloves and sleeves, 
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and the sterile barrier is reestablished. If the neonate exhibits no signs of distress, it 
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remains in SSC with the mother for as long as possible, ideally throughout the cesarean. 
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The obstetric nurse monitors the neonate during SSC and assists the mother in holding 
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the newborn. In cases of maternal or neonatal discomfort, the neonate may be handed 
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to an obstetric nurse or pediatrician. All neonates are examined by the pediatrician 
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within an hour post-delivery in the recovery ward. 
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2.6.2 Immediate SSC and early breastfeeding initiation 
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Upon birth, the neonate is promptly placed prone on the mother’s chest, with their 
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head turned to one side for optimal skin contact. The drying process begins within 5 
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seconds and is completed within 20 to 30 seconds while the neonate remains on the 
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mother’s chest. Delayed cord clamping is practiced, with the cord clamped 
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approximately 1-3 minutes after birth. Breastfeeding cues such as tongue movements 
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or head turning are monitored, and the obstetric nurse assists the mother in initiating 
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breastfeeding as soon as possible. SSC continues throughout the cesarean procedure, 
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and upon completion, the newborn is temporarily separated from the mother for safety 
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during transfer to the surgical cart. SSC is resumed immediately post-transfer and 
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continues for a cumulative duration of at least 90 minutes. The neonate’s skin color, 
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breathing, and feeding responses are continuously observed. 
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2.6.3 Routine newborn care 
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Newborn eye care, vitamin K1 administration, immunizations, weighing, and 
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standard examinations are conducted before the neonate is transferred to the ward. 
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2.7 Control Group (CG) 
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2.7.1 Delayed SSC and breastfeeding 
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The neonate is dried within 20-30 seconds after birth, the cord is clamped after 1-
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3 minutes, and then the neonate is sent to the ward to wait for the mother to complete 
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the surgery. Immediate SSC is initiated within one hour after birth and maintained with 
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the mother for at least 90 minutes post-surgery, during which the neonate’s skin color 
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and breathing are continuously monitored. The obstetric nurse supports the mother in 
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initiating breastfeeding at the earliest opportunity. 
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2.7.2 Routine newborn care 
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Newborn eye care, vitamin K1 administration, immunizations, weighing, and 
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standard examinations are conducted before the neonate is transferred to the ward. 
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2.8 Outcome Indicators 
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IMMEDIATE SKIN-TO-SKIN CONTACT DURING CAESAREAN SECTION 
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2.8.1 Primary outcome 
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(A) Incidence of neonatal hypoglycemia: Neonatal blood glucose levels will be 
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assessed using the Stat Strip Xpress glucose meter at 1, 3, and 6 hours after birth. 
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Hypoglycemia is categorized as follows: mild hypoglycemia (overall) at <45 mg/dL, 
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moderate-to-severe at <36 mg/dL, and severe at <18 mg/dL. Treatment will be 
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initiated if levels dropped below 25 mg/dL or if symptoms like shakiness, tachycardia, 
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pallor, hypothermia, hunger, sweating, or weakness appeared8. In such cases, 10 
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ml/kg of formula will be administered, followed by a recheck after 0.5 hour. If levels 
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rise above 40 mg/dL, subsequent checks occurs every 3 hours9. Persistent levels 
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below 50 mg/dL necessitates continued formula feeding and monitoring, or 
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transferred to neonatal care if needed. 
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2.8.2 Secondary outcome 
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(A) Breastfeeding initiation and duration of first breastfeeding, characterized by 
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newborns correctly latching onto the nipple and areola, and establishing regular, 
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effective sucking and swallowing, will be immediately assessed post-operation, with 
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timing recorded to the minute. 
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(B) Onset of lactogenesis II, approximately 72 hours post-delivery, marked by 
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significant milk secretion perceived by the mother as breast fullness, confirmed by 
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observing and squeezing the areola to assess milk spillage, will be assessed from 
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delivery to pre-discharge, with timing recorded to the hour postpartum. 
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(C) Exclusive breastfeeding rate during hospitalization, where newborns are 
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exclusively breastfed except for vitamins and minerals. This rate will be calculated for 
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mothers who underwent cesarean delivery in both study groups. 
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2.9 Data Collection and Management 
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Researchers will contact all women scheduled for cesarean deliveries within 24 
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hours before the procedure. Led by the principal investigator and an experienced 
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research assistant, the team will conduct face-to-face interviews to gather 
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demographic and obstetric information. Details regarding the duration of SSC, the 
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initiation and duration of the first breastfeeding session, exclusive breastfeeding 
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IMMEDIATE SKIN-TO-SKIN CONTACT DURING CAESAREAN SECTION 
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during hospitalization, as well as the infant’s safety and blood glucose levels, will be 
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continuously collected and recorded by trained staff during and after elective cesarean 
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sections. All data will be anonymized and de-identified for further evaluation. 
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2.10 Sample Size 
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The sample size was determined based on a preliminary trial with 258 
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participants5. In this trial, the Early Essential Newborn Care (EENC) group exhibited 
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a lower incidence of neonatal hypoglycemia compared to the control group receiving 
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conventional care (0 vs. 5.3%, P=0.007). Using G*Power software version 3.1.7, with 
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a two-sided type I error (α) of 0.05, a power (1 - β) of 90%, test family set to ‘exact,’ 
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and the statistical test ‘proportions: inequality, two independent groups,’ it was 
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calculated that at least 148 patients were required in each group. To account for an 
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anticipated 20% dropout rate, the total sample size was adjusted to 356 participants, 
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with 178 allocated to each group. 
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2.11 Statistical Analysis 
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The data analysis will be performed using SPSS 21.0 (SPSS Inc., Chicago, IL). 
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Quantitative variables will be expressed as mean ± standard deviation. The T-test will 
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be employed for normally distributed data, while the Mann-Whitney U test will be 
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used for non-normally distributed data. Categorical variables will be summarized as 
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frequencies and percentages and analyzed with the Chi-squared test. All statistical 
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tests are two-sided, and a P-value of less than 0.05 is considered significant. 
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2.12 Ethics 
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This study will adhere to the ethical standards set by the relevant institutional and 
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national review committees. Approval was granted by the Institutional Research 
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Human or Animal Ethics Committee of Qingdao Municipal Hospital (2023 Lin Shen 
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Zi No. 122), and all procedures complied with the revised 2013 Declaration of 
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Helsinki.  
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