Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498882
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-06-28
Brief Title:
Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II
Sponsor:
Qingdao Municipal Hospital
Organization:
Qingdao Municipal Hospital
Study Overview
Official Title:
Impact of Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This RCT aimed to rigorously evaluate the combined effects of press needle acupuncture and breast massage on accelerating the onset of lactogenesis II thereby optimizing breastfeeding outcomes and maternal health post-cesarean delivery It involved 136 mothers who had cesarean sections at this facility along with their healthy single-born infants
Control group received routine care On the basis of the control group press needle acupoint stimulation and breast massage were administered to the intervention group The main outcome indicators included the sensation of milk coming in defined as the time to stage II lactogenesis Additionally milk quality was assessed 72 hours after birth focusing on the content of protein fat lactose minerals and water Secondary outcomes tracked include the number of breastfeeding sessions within the first 72 hours the milliliters of formula provided to the infant during this period and the percentage of mothers exclusively breastfeeding after 72 hours
Control group received routine care On the basis of the control group press needle acupoint stimulation and breast massage were administered to the intervention group The main outcome indicators included the sensation of milk coming in defined as the time to stage II lactogenesis Additionally milk quality was assessed 72 hours after birth focusing on the content of protein fat lactose minerals and water Secondary outcomes tracked include the number of breastfeeding sessions within the first 72 hours the milliliters of formula provided to the infant during this period and the percentage of mothers exclusively breastfeeding after 72 hours
Detailed Description:
This RCT aimed to rigorously evaluate the combined effects of press needle acupuncture and breast massage on accelerating the onset of lactogenesis II thereby optimizing breastfeeding outcomes and maternal health post-cesarean delivery It involved 136 mothers who had cesarean sections at this facility along with their healthy single-born infants
Control group Very early skin-to-skin contact was initiated by researchers within 30 to 40 minutes after birth with newborns optionally wearing caps being placed on the motherschests Mothers were encouraged to breastfeed 8 to 10 times per day to ensure steady milk production Additionally mothers were guided by researchers on maintaining a well-balanced diet achieving emotional stability and securing adequate sleep to facilitate effective breastfeeding
Intervention group On the basis of the control group press needle acupoint stimulation and breast massage were administered to the intervention group
Primary Outcome Measurement The main outcome indicators included the sensation of milk coming in defined as the time to stage II lactogenesis Participants were asked to report the approximate time they noticed their breasts feeling noticeably fuller using a numeric scale 1 indicated no change since giving birth 3 denoted noticeably fuller and 5 represented uncomfortably full Lian et al 2022 Additionally milk quality was assessed 72 hours after birth focusing on the content of protein fat lactose minerals and water
Secondary Outcome Measurements Secondary outcomes tracked include the number of breastfeeding sessions within the first 72 hours breastfeeds first 24 h 24-48 h 48-72 h the milliliters of formula provided to the infant during this period formula fed to infant first 24 h 24-48 h 48-72 h and the percentage of mothers exclusively breastfeeding after 72 hours
Control group Very early skin-to-skin contact was initiated by researchers within 30 to 40 minutes after birth with newborns optionally wearing caps being placed on the motherschests Mothers were encouraged to breastfeed 8 to 10 times per day to ensure steady milk production Additionally mothers were guided by researchers on maintaining a well-balanced diet achieving emotional stability and securing adequate sleep to facilitate effective breastfeeding
Intervention group On the basis of the control group press needle acupoint stimulation and breast massage were administered to the intervention group
Primary Outcome Measurement The main outcome indicators included the sensation of milk coming in defined as the time to stage II lactogenesis Participants were asked to report the approximate time they noticed their breasts feeling noticeably fuller using a numeric scale 1 indicated no change since giving birth 3 denoted noticeably fuller and 5 represented uncomfortably full Lian et al 2022 Additionally milk quality was assessed 72 hours after birth focusing on the content of protein fat lactose minerals and water
Secondary Outcome Measurements Secondary outcomes tracked include the number of breastfeeding sessions within the first 72 hours breastfeeds first 24 h 24-48 h 48-72 h the milliliters of formula provided to the infant during this period formula fed to infant first 24 h 24-48 h 48-72 h and the percentage of mothers exclusively breastfeeding after 72 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None