Clinical trial NCT06543160: Immediate Skin-To-Skin Contact and Early Breastfeeding During Caesarean Section
Official title: Immediate Skin-to-Skin Contact and Breastfeeding During Caesarean Section: A Randomized Controlled Trial on Early Neonatal Hypoglycemia in Late Preterm and Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Hypoglycemia
Keywords: neonatal hypoglycemia
skin-to-skin contact
breastfeeding
cesarean section
lactogenesis
Lead sponsor: Qingdao Municipal Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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:

Experimental Group:

1. SSC and Breastfeeding During CS: Immediately after delivery, the surgical drape was lowered for parents to witness the birth. The neonate was placed prone on the mother's chest and dried within 20-30 seconds. Breastfeeding was initiated as soon as possible, and SSC continued throughout the surgery and for at least 90 minutes post-transfer to the ward.
2. Routine Newborn Care: Included standard newborn care such as eye care, vitamin K1 administration, immunizations, and weighing, conducted before transferring the neonate to the ward.

Control Group:

1. Delayed SSC and Breastfeeding: SSC was initiated within one hour after birth and maintained for at least 90 minutes post-surgery. The neonate was dried within 20-30 seconds after birth and sent to the ward while the mother completed the surgery.
2. Routine Newborn Care: Similar to the experimental group.

Outcome Measures:

Primary Outcome: Incidence of neonatal hypoglycemia, with blood glucose levels monitored at 1, 3, and 6 hours post-birth using the Stat Strip Xpress glucose meter. Hypoglycemia was categorized as mild (\<45 mg/dL), moderate-to-severe (\<36 mg/dL), and severe (\<18 mg/dL).

Secondary Outcomes: Included time to breastfeeding initiation, duration of the first breastfeeding session, onset of lactogenesis II (significant milk secretion perceived by the mother), and rate of exclusive breastfeeding during hospitalization.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of neonatal hypoglycemia
timeFrame: 1, 3, and 6 hours after birth
Secondary outcomes:
measure: Breastfeeding initiation time
timeFrame: Assessment occurs immediately post-operation, with timing recorded to the minute.
measure: Duration of first breastfeeding
timeFrame: Assessment occurs immediately post-operation, with timing recorded to the minute.
measure: Onset of lactogenesis II
timeFrame: The assessment occurs from surgery to pre-discharge, with timing recorded to the hour postpartum, an average of 72 hours.
measure: Exclusive breastfeeding rate during hospitalization
timeFrame: The assessment occurs from delivery to pre-discharge, an average of 5 days.
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
Study officials:
affiliation: Qingdao Municipal Hospital
name: Jia Qiao
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cuschieri S. The CONSORT statement. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S27-S30. doi: 10.4103/sja.SJA_559_18.
citation: 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.
citation: 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.