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Comparison of the success of nipple shield to exclusive breast feeding in mothers with problematic nipples with late preterm and term delivery a randomized controlled trial

Phase 1
Conditions
nipple shield, problematic nipples (short, flat, invert nipples) and cracked nipple and breast feeding
nipple shield, short nipples, flat nipples, invert nipples, cracked nipples
Registration Number
TCTR20220914003
Lead Sponsor
Faculty of Medicine, Siriraj Hospital, Mahidol University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
Female
Target Recruitment
660
Inclusion Criteria

1. The mother is 18 years of age or older.
2. Single mothers after giving birth, gestational age from 34 weeks onwards.
3. Mothers with nipple abnormalities such as short nipples (nipple length less than 0.7 cm), flat nipples, invert nipples, or cracked nipples.
4. Mothers who can use a nipple shield (nipple shield)
5. Mothers who have confirmed that they will be able to cooperate in contact to answer questions about breastfeeding during the first 6 months after giving birth.
6. Mothers who signed their consent to participate in the research.

Exclusion Criteria

1. Mothers who cannot understand Thai and communicate in Thai
2. Mothers who are prohibited from breastfeeding
3. Mothers who are allergic to nipple shields
4. Newborns are unable to breastfeed.
5. Mothers who cannot be contacted during the first 6 months or have immigrated abroad.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
exclusive breast feeding 6 months only breast feeding until 6 months post-partum
Secondary Outcome Measures
NameTimeMethod
exclusive breast feeding in 1, 2, 3 and 6months 1, 2, 3 and 6 months following up only breast feeding in 1, 2, 3 and 6 months,exclusive breast feeding in late preterm and term delivery 1, 2, 3 and 6 months following up only breast feeding in 1, 2, 3 and 6 months
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