Immediate Skin-To-Skin Contact and Early Breastfeeding During Caesarean Section

NCT06543160 | Completed

• 1 other identifier: Grant No.(2023LinShenZi No.123
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

neonatal hypoglycemia; skin-to-skin contact; breastfeeding; cesarean section; lactogenesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Breastfeeding initiation time

  Assessment occurs immediately post-operation, with timing recorded to the minute.

• 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.

• Exclusive breastfeeding rate during hospitalization

  The assessment occurs from delivery to pre-discharge, an average of 5 days.

Study Arms (2)

Immediate SSC and early breastfeeding during CS group

EXPERIMENTAL

Receiving immediate SSC and early breastfeeding during CS and routine newborn care

Other: Immediate SSC and early breastfeeding during CS; Other: Routine newborn care

control group

OTHER

Receiving delayed SSC and breastfeeding and routine newborn care

Other: Delayed SSC and breastfeeding after CS; Other: Routine newborn care

Interventions

Immediate SSC and early breastfeeding during CS OTHER

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.

Immediate SSC and early breastfeeding during CS group

Delayed SSC and breastfeeding after CS OTHER

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.

control group

Routine newborn care OTHER

Newborn eye care, vitamin K1 administration, immunizations, weighing, and standard examinations are conducted before the neonate is transferred to the ward.

Immediate SSC and early breastfeeding during CS group; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qingdao Municipal Hospital: lead

Study Sites (1)

Qingdao Municipal Hospital

Qingdao, Shandong, 266000, China

Location

Related Publications (3)

• Cuschieri S. The CONSORT statement. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S27-S30. doi: 10.4103/sja.SJA_559_18.

  PMID: 30930716 BACKGROUND

• Wang X, Zhang X, Sobel HL, Li Z, Juan J, Yang H. Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial. Trials. 2022 Aug 19;23(1):696. doi: 10.1186/s13063-022-06615-z.

  PMID: 35986372 BACKGROUND

• Roeper M, Hoermann H, Kummer S, Meissner T. Neonatal hypoglycemia: lack of evidence for a safe management. Front Endocrinol (Lausanne). 2023 Jun 8;14:1179102. doi: 10.3389/fendo.2023.1179102. eCollection 2023.

  PMID: 37361517 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Jia Qiao

  Qingdao Municipal Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 7, 2024
• Study Start: July 1, 2023
• Primary Completion: May 15, 2024
• Study Completion: July 20, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)