Clinical trial NCT06498882: Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II
Official title: Impact of Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactation Induced
Keywords: press needle
acupoint stimulation
breast massage
lactogenesis II
breastfeeding sessions
breast milk composition
Lead sponsor: Qingdao Municipal Hospital
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: time to stage II lactogenesis
timeFrame: 0-96 hours after delivery
measure: milk quality
timeFrame: 72 hours after delivery
Secondary outcomes:
measure: number of breastfeeding sessions
timeFrame: a) 0-24 hours, 24-48 hours, 48-72 hours after delivery
measure: milliliters of formula provided to the infant
timeFrame: 0-24 hours, 24-48 hours, 48-72 hours after delivery
measure: percentage of mothers exclusively breastfeeding
timeFrame: 72 hours after delivery
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
Study officials:
affiliation: Qingdao Municipal Hospital
name: Shan-Shan Huan, Bachelor
role: STUDY_DIRECTOR
affiliation: Qingdao Municipal Hospital
name: Jia Qiao, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.