Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543160
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Immediate Skin-To-Skin Contact and Early Breastfeeding During Caesarean Section
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 341 and 416 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 eg placenta previa eclampsia conditions hindering SSC initiation eg 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 mothers 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 mgdL moderate-to-severe 36 mgdL and severe 18 mgdL
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
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 341 and 416 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 eg placenta previa eclampsia conditions hindering SSC initiation eg 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 mothers 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 mgdL moderate-to-severe 36 mgdL and severe 18 mgdL
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None