Clinical trial NCT05066100: Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples
Official title: Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples to Improve Postpartum Breastfeeding Rates
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Inverted Nipple
Retracted Nipple
Keywords: Pregnancy
Lactation
Postpartum
Flat Nipples
Inverted Nipples
Retracted Nipples
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of women with change in nipple elongation following use of Supple Cups in the prenatal period
timeFrame: At completion of 6 weeks of Supple Cups use during the prenatal period
Secondary outcomes:
measure: Percent of women with established breastfeeding with adequate infant latch
timeFrame: One week postpartum
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Miriam E Levi, CNM, MBA
role: PRINCIPAL_INVESTIGATOR
References: