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A Randomized Controlled Study on Lactation Effect and Comfort of Micro-vibration Lactation Breast Pumps vs. Traditional Breast Pumps in Postpartum Women

A Randomized Controlled Study on Lactation Effect and Comfort of Micro-vibration Lactation Breast Pumps vs. Traditional Breast Pumps in Postpartum Women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129259
Enrollment
Unknown
Registered
2026-08-03
Start date
2025-11-19
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blocked Milk Ducts and Low Milk Supply

Interventions

experimental group:Using the BOLOLO brand micro-vibration breast pump
control group:Using a Medela manual breast pump

Sponsors

The Tenth People's Hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
24 Years to 44 Years

Inclusion criteria

Inclusion criteria: 1. Full-term mothers: Those who give birth at =37–<42 weeks of gestation and experience difficulties such as poor milk flow, breast engorgement, or insufficient milk supply during the postpartum period, requiring the use of a breast pump. 2. Mother-baby rooming-in: Ensure that the newborn can remain with the mother for breastfeeding or breast pumping, to facilitate continuous monitoring and recording of milk production and the newborn’s growth and development. 3. Stable postpartum health: The mother’s postpartum health is stable, with no significant infections, bleeding, or other health issues that could affect lactation. 4. First lactation time requirement: The first lactation must occur within 12 hours postpartum. 5. Willingness to accept and comply with the study protocol: Participants must be willing and able to use a breast pump as required by the study and be willing to undergo follow-up and monitoring throughout the study period. If a participant is temporarily unable to use a breast pump due to her physical condition (e.g., health issues), the study period will be extended by the number of days during which the breast pump could not be used. For example, if a participant is unable to participate in the study due to a 5-day hospital stay, the entire study period will be extended by 5 days to ensure complete data collection and the continuity of the study.

Exclusion criteria

Exclusion criteria: 1. Neonatal jaundice requiring treatment: Exclude cases where phototherapy or other specialized jaundice treatments are required within 72 hours of birth. 2. Mother-infant separation: Situations where mother and infant must be separated for any reason, such as when the newborn requires admission to the NICU (Neonatal Intensive Care Unit), resulting in the inability to breastfeed or use a breast pump normally. 3. Pregnancy complications: Excludes pregnant women with severe complications during pregnancy, including gestational hypertension, gestational hyperglycemia, acute fatty liver of pregnancy, intrahepatic cholestasis of pregnancy, and fetal growth restriction. 4. Postpartum complications: Postpartum hemorrhage, severe infections affecting breastfeeding, and other conditions that affect postpartum breastfeeding. 5. Inability to use a breast pump as required by the study, or withdrawal from the study during the study period for personal reasons.

Design outcomes

Primary

MeasureTime frame
Unblocking milk ducts;Increase milk production;

Secondary

MeasureTime frame
Effectiveness in relieving breast engorgement and swelling;Comfort;

Countries

China

Contacts

Public ContactDi Zhang

The Tenth People's Hospital of Shanghai

adi623@163.com+86 137 6155 5579

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026