Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| press needle acupoint stimulation combined with breast massage group | Experimental | On the basis of the routine care, press needle acupoint stimulation and breast massage were administered to the intervention group |
|
| control group | Other | Control group received routine care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Press Needle Acupoint Stimulation Combined with Breast Massage | Other | Press needle acupoint stimulation and breast massage were administered. Key press needle acupoints were identified for selection: Dan zhong (RN17), bilateral Ru gen (ST18), bilateral Shao ze (SI1), bilateral Zu san li (ST36) and bilateral San yin jiao (SP6). The areas were sterilized with 75% alcohol before installing 0.22*1.55mm press needles. Within 4-6 hours post-surgery, mothers received acupoint stimulation through needle pressing. This procedure was administered by nurses who had undergone six-month standardized training in traditional Chinese medicine techniques. Instructions were then given to mothers and their family members to stimulate the acupoints pulsatively every 3-4 hours for 20-30 minutes per session, removing the press needles after 24 hours. Additionally, a specialized nurse massaged the back, both breast areas, and armpits for 10-15 minutes, three times daily over three days, using a circular and oscillating breast massage device. |
| Measure | Description | Time Frame |
|---|---|---|
| time to stage II lactogenesis | 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). | 0-96 hours after delivery |
| milk quality | Milk quality was assessed 72 hours after birth, focusing on the content of protein, fat, lactose, minerals, and water. | 72 hours after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| number of breastfeeding sessions | Secondary outcomes tracked include the number of breastfeeding sessions within the first 72 hours (breastfeeds, 0-24 hours, 24-48 hours, 48-72 hours) | a) 0-24 hours, 24-48 hours, 48-72 hours after delivery |
| milliliters of formula provided to the infant |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shan-Shan Huan, Bachelor | Qingdao Municipal Hospital | Study Director |
| Jia Qiao, Master | Qingdao Municipal Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qingdao Municipal Hospital | Qingdao | Shandong | 266000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34130991 | Background | Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021 Jun;6(6):e005671. doi: 10.1136/bmjgh-2021-005671. | |
| 27684560 | Background | Becker GE, Smith HA, Cooney F. Methods of milk expression for lactating women. Cochrane Database Syst Rev. 2016 Sep 29;9(9):CD006170. doi: 10.1002/14651858.CD006170.pub5. |
| Label | URL |
|---|---|
| view only | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Sharing study protocol.
31/08/2025 to 31/08/2018
On reasonable request
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| routine care | Other | 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. It was ensured by researchers that mothers completely emptied one breast before switching to the other to maintain cleanliness. Additionally, mothers were guided by researchers on maintaining a well-balanced diet, achieving emotional stability, and securing adequate sleep to facilitate effective breastfeeding. |
|
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) |
| 0-24 hours, 24-48 hours, 48-72 hours after delivery |
| percentage of mothers exclusively breastfeeding | Secondary outcomes tracked include the percentage of mothers exclusively breastfeeding after 72 hours. | 72 hours after delivery |
The authors have full control of all primary data and that they agree to allow other researchers to review their data if requested. |