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Open label study to compare breastfeeding difficulty between Lactamo using group and lactation counselling group among lactating mothers

Comparison of breastfeeding difficulty between Lactamo using group and lactation counselling group among lactating mothers - Open-label randomized study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084653
Enrollment
94
Registered
2025-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

None listed

Interventions

Intervention1: Lactamo balls: Lactamo is a reusable, soft, medical grade silicone massage ball specifically developed and designed for lactating breasts. It is manual, self-operated and designed for h

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy, full term 37 weeks or greater gestational age post natal woman at the IP ward of Cloudnine between the ages of 21 to 35 with appropriate weight for gestation age. Willing to participate and use the product as prescribed by the treating lactation counsellor

Exclusion criteria

Exclusion criteria: Mother who had complications at delivery like severe PPH, eclampsia and pre eclampsia Mother whose baby is in the NICU BMI more than 30 kg per meter square. Mother whose baby had congenital problem, cleft lip, palate and abnormalities in oral cavity, tongue tie. Mother in whom breast feeding is contraindicated Baby who started on formula feed before randomization

Design outcomes

Primary

MeasureTime frame
Breastfeeding difficulty level between Lactamo using group and lactation counselling group.Timepoint: One month from Enrolment

Secondary

MeasureTime frame
Average weight gain of infant between Lactamo using group and lactation counselling group.Timepoint: One month from enrolment

Countries

India

Contacts

Public ContactProf Dr Kishore Kumar R

Kids Clinic India Ltd

drkishore@cloudninecare.com9972899728

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026