Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II
- Conditions
- Lactation Induced
- Interventions
- Other: Press Needle Acupoint Stimulation Combined with Breast MassageOther: routine care
- Registration Number
- NCT06498882
- Lead Sponsor
- Qingdao Municipal Hospital
- 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.
- 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 mothers'chests. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 132
- Mothers ≥18 years old
- Expecting their first live-born child via cesarean delivery
- Having a singleton pregnancy
- Intending to breastfeed with no major contraindications like hepatitis B, HIV, or other infectious diseases
- Having newborns with Apgar scores above 8 at 1 and 5 minutes, robust sucking reflex, and no neonatal transfer required
- Able to understand and respond to questions
- Accessible for follow-up via telephone or WeChat
- Mothers having previous breast surgeries like biopsies or augmentations
- Having nipple inversions that complicate breastfeeding; (c) taking medications affecting lactation
- Experiencing severe perinatal complications, such as serious pre-eclampsia or grade 3 or higher cardiac issues per NYHA standards
- Having severe local skin damage at the acupoint and massage sites
- Having newborns with critical conditions like cardiopulmonary insufficiency, galactosemia, or phenylketonuria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description press needle acupoint stimulation combined with breast massage group Press Needle Acupoint Stimulation Combined with Breast Massage On the basis of the routine care, press needle acupoint stimulation and breast massage were administered to the intervention group press needle acupoint stimulation combined with breast massage group routine care On the basis of the routine care, press needle acupoint stimulation and breast massage were administered to the intervention group control group routine care Control group received routine care
- Primary Outcome Measures
Name Time Method time to stage II lactogenesis 0-96 hours after delivery 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).
milk quality 72 hours after delivery Milk quality was assessed 72 hours after birth, focusing on the content of protein, fat, lactose, minerals, and water.
- Secondary Outcome Measures
Name Time Method milliliters of formula provided to the infant 0-24 hours, 24-48 hours, 48-72 hours after delivery Secondary outcomes tracked include the milliliters of formula provided to the infant during this period (formula fed to infant, 0-24 hours, 24-48 hours, 48-72 hours)
number of breastfeeding sessions a) 0-24 hours, 24-48 hours, 48-72 hours after delivery Secondary outcomes tracked include the number of breastfeeding sessions within the first 72 hours (breastfeeds, 0-24 hours, 24-48 hours, 48-72 hours)
percentage of mothers exclusively breastfeeding 72 hours after delivery Secondary outcomes tracked include the percentage of mothers exclusively breastfeeding after 72 hours.
Trial Locations
- Locations (1)
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China