How to Help Mothers with Inverted Nipples Breastfeed Successfully

To determine the value of recommending breast sucking by older child or someone else in the family member in lactating women with inverted or non-protractile nipples who intend to breast feed, compared to traditional treatment by syringe method, Hoffman technique or breast pump - Nil

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086795

Enrollment

Registered

2025-05-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

None listed

Interventions

Intervention1: Human intervention: In the intervention group, pregnant women identified with inverted or non-protractile nipples who express a desire to breastfeed will receive structured counselling

Eligibility

Inclusion criteria

Inclusion criteria: Primiparous women recruited aged between 20 and 35 yrs, who delivered the baby either normal vaginal delivery or by caesarian section with at least one inverted or nonprotractile nipple.

Exclusion criteria

Exclusion criteria: We will exclude women with grade 3 inverted nipples, previous breast surgery affecting the breast anatomy, high risk pregnancies, medical conditions that may interfere with breastfeeding, including a critical maternal condition, newborns with congenital malformations such as esophageal atresia, cleft lip, and/or palate, and women choosing artificial milk as their preferred infant nutrition.

Design outcomes

Primary

Measure	Time frame
differences between the two groups in the rates of nipple eversion at 1 month, successful latching of the infant on mother s breast at 1 month, exclusive breastfeeding at 3 and 6 months, mixed feeding at 1, 3, and 6 monthsTimepoint: baseline, 4 weeks, 12 weeks and 24 weeks	—

Secondary

Measure	Time frame
breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, and breast engorgement at 1 week, 1, 3, and 6 months postpartum. Other secondary outcomes are maternal satisfaction with breastfeeding assessed at 1 week postpartum using the validated Maternal Breastfeeding Evaluation Scale and maternal quality of life assessed at 1 month using the validated Postpartum Quality of Life instrumentTimepoint: 1week, 1, 3, 6 months	—

Measure

Time frame

breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, and breast engorgement at 1 week, 1, 3, and 6 months postpartum. Other secondary outcomes are maternal satisfaction with breastfeeding assessed at 1 week postpartum using the validated Maternal Breastfeeding Evaluation Scale and maternal quality of life assessed at 1 month using the validated Postpartum Quality of Life instrumentTimepoint: 1week, 1, 3, 6 months

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Countries

India

Contacts

Public ContactDr Yashwant Rao

GSVM Medical College

ykraoneo@yahoo.co.in9919080807

Outcome results