Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples

Not Applicable

Withdrawn

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Pregnant women with FIRN	Prenatal Use of Supple Cups	Women desiring to breastfeed and identified during their pregnancy as having flat, inverted or retracted nipples

Primary Outcome Measures

Name	Time	Method
Percent of women with change in nipple elongation following use of Supple Cups in the prenatal period	At completion of 6 weeks of Supple Cups use during the prenatal period	Visual assessment and documented description of change in elongation of nipple after using Supple Cups prior to birth

Secondary Outcome Measures

Name	Time	Method
Percent of women with established breastfeeding with adequate infant latch	One week postpartum	Visual assessment and documentation of a consistent infant latch during breastfeeding for the women who utilized Supple Cups in the prenatal period.

Locations (1): Mayo Clinic in Rochester, Minnesota
🇺🇸
Rochester, Minnesota, United States

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