NCT05066100

Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples

Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples to Improve Postpartum Breastfeeding Rates

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to determine the population occurrence rate of flat, inverted, or retracted nipples (FIRN) in pregnant women in our obstetrical practice through prenatal evaluation at the NOB visit and re-evaluation at the 28th-30th week of gestation, to determine the benefit of using Supple Cups as treatment for FIRN for 6-8 weeks in the third trimester to evert the nipples prior to delivery, and to evaluate the effect of prenatal diagnosis and treatment of FIRN on establishment of latch and breastfeeding rates in the postpartum period.

Detailed description

It is well established that breastfeeding is the most clinically optimal method of feeding for infants through the first year of life, however exclusive breastfeeding rates in the United States remain low. Many women have difficulty establishing breastfeeding in the first few weeks after birth which leads to the use of formula supplementation. For approximately 10% of women this difficulty is caused by flat, inverted or retracted nipples (FIRN) which make it very difficult to latch when attempting to breastfeed. Many women are not diagnosed with FIRN until after the baby is born. Supple Cups are promising as a prenatal and postnatal intervention to elongate nipples in cases of FIRN, allowing women with these biological variations to successfully breastfeed. If women are diagnosed in the early prenatal period with FIRN, Supple Cup use can be initiated to elongate and prepare the nipples for breastfeeding postpartum. Pre-natal diagnosis of FIRN is critical to enable breastfeeding immediately postpartum.

Conditions

• Inverted Nipple
• Retracted Nipple

Interventions

Type	Name	Description
OTHER	Prenatal Use of Supple Cups	For pregnant women identified with FIRN and providing consent to participate in this study, Supple Cup usage will be initiated at 32 weeks gestation to begin to elongate the nipples in preparation for breastfeeding.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-12-01
• Completion: 2024-03-01
• First posted: 2021-10-04
• Last updated: 2022-12-15

Locations

1 site across 1 country: United States