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

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220914003

Enrollment

660

Registered

2022-09-14

Start date

2023-01-01

Completion date

Unknown

Last updated

2026-08-03

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

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

Interventions

Singleton pregnant women who delivered after 34 weeks of gestation with problematic nipple including short, flat, invert or cracked nipples will be advice to use nipple shield during breast feeding.

Experimental Device,No Intervention No treatment

Nipple shield applying,No intervention

Eligibility

Sex/Gender

Female

Age

18 Years to 50 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
exclusive breast feeding 6 months only breast feeding until 6 months post-partum	—

Secondary

Measure	Time frame
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	—

Countries

Thailand

Contacts

Public ContactSaifon Chawanpaiboon

Faculty of Medicine, Siriraj Hospital, Mahidol University

saifon.cha@mahidol.ac.th2894436106

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026