Lactation InducedNCT06498882
Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II
A study testing Press Needle Acupoint Stimulation Combined with Breast Massage and routine care in people with Lactation Induced, run by Qingdao Municipal Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation Induced
- What is being tested?
- Press Needle Acupoint Stimulation Combined with Breast Massage and routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2023to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Lactation Induced
- Being tested
- Press Needle Acupoint Stimulation Combined with Breast Massage, routine care
- Keywords
- press needle, acupoint stimulation, breast massage, lactogenesis II, breastfeeding sessions, breast milk composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Press Needle Acupoint Stimulation Combined with Breast MassageOther
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.
routine careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Press Needle Acupoint Stimulation Combined with Breast Massage; Other: routine care |
| control group | Other | Control group received routine care Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 72 hours after delivery
Secondary outcomes (3)
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)
Measured: a) 0-24 hours, 24-48 hours, 48-72 hours after delivery
milliliters of formula provided to the infant
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)
Measured: 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.
Measured: 72 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start28 Dec 2023
- Primary completion15 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lactation InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingdao Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Qiao, Qingdao Municipal Hospital
- Investigators
- Shan-Shan Huan, Bachelor, Study director, Qingdao Municipal HospitalJia Qiao, Master, Principal investigator, Qingdao Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498882
- Sponsor's protocol ID
- Grant No.(2023LinShenZi No.122
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing study protocol.
Publications
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.
PubMed 34130991Becker 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.
PubMed 27684560Gao T, Cao QN, Qiao J. Impact of Press Needle Combining Breast Massage on Onset of Lactogenesis II in Post-Cesarean Mothers: A Randomized Controlled Trial. Chin J Integr Med. 2026 Jul 28. doi: 10.1007/s11655-026-4245-2. Online ahead of print.
PubMed 42518113
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06498882
- Acronym / sponsor ID
- Grant No.(2023LinShenZi No.122
- Conditions
- Lactation Induced
- Keywords
- press needle, acupoint stimulation, breast massage, lactogenesis II, breastfeeding sessions, breast milk composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Qingdao Municipal HospitalUniversity, hospital or other
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| press needle acupoint stimulation combined with breast massage group | Experimental | Other: Press Needle Acupoint Stimulation Combined with Breast Massage, Other: routine careOn the basis of the routine care, press needle acupoint stimulation and breast massage were administered to the intervention group |
| control group | Other | Other: routine careControl group received routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Press Needle Acupoint Stimulation Combined with Breast MassagePress 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. | Other | press needle acupoint stimulation combined with breast massage group |
| routine careVery 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. | Other | control group, press needle acupoint stimulation combined with breast massage group |
Primary outcome
time to stage II lactogenesis
Time frame: 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
Time frame: 72 hours after delivery
Milk quality was assessed 72 hours after birth, focusing on the content of protein, fat, lactose, minerals, and water.
3 secondary outcomes
number of breastfeeding sessions
Time frame: a) 0-24 hours, 24-48 hours, 48-72 hours after delivery
milliliters of formula provided to the infant
Time frame: 0-24 hours, 24-48 hours, 48-72 hours after delivery
percentage of mothers exclusively breastfeeding
Time frame: 72 hours after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 34130991Betran 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.
- Background: PubMed 27684560Becker 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.
- Derived from this study: PubMed 42518113Gao T, Cao QN, Qiao J. Impact of Press Needle Combining Breast Massage on Onset of Lactogenesis II in Post-Cesarean Mothers: A Randomized Controlled Trial. Chin J Integr Med. 2026 Jul 28. doi: 10.1007/s11655-026-4245-2. Online ahead of print.
- view onlyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Sharing study protocol.
Related trials for Lactation Induced
RecruitingObservational study
Birth & Breastfeeding Support Study
Breastfeeding, Breastfeeding Initiation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shan-Shan Huan, Bachelor study director
Qingdao Municipal Hospital
Jia Qiao, Master principal investigator
Qingdao Municipal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Press Needle Acupoint Stimulation Combined with Breast Massage and routine care in people with Lactation Induced, run by Qingdao Municipal Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to stage II lactogenesis (time frame: 0-96 hours after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06498882, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.