Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples

Mayo Clinic

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Inverted Nipple Retracted Nipple

Interventions

Prenatal Use of Supple CupsOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women ≥ 18 years of age * Pregnant at time of enrollment * Plan to breastfeed their infant following birth * Plan delivery at Mayo Clinic Hospital * One or more flat, inverted or retracted nipple diagnosed by a healthcare professional Exclusion Criteria: * History of breast surgery or nipple piercings * History of significant low milk supply requiring discontinuation of breastfeeding prior to six weeks postpartum * History of preterm labor and/or birth * History of high-risk medical condition that increases patient risk for preterm labor and/or birth * History of Raynaud's syndrome and/or hypersensitivity to palpation of breasts * Current multiple gestation pregnancy * Active rash, infection, or lesions on the nipple at time of initiation of Supple Cups

Locations (1)

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Percent of women with change in nipple elongation following use of Supple Cups in the prenatal period

Visual assessment and documented description of change in elongation of nipple after using Supple Cups prior to birth

Time frame: At completion of 6 weeks of Supple Cups use during the prenatal period

Secondary Outcomes

Percent of women with established breastfeeding with adequate infant latch

Visual assessment and documentation of a consistent infant latch during breastfeeding for the women who utilized Supple Cups in the prenatal period.

Time frame: One week postpartum

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.