Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples

Withdrawn before enrolling · Not applicable

Conditions studied: Inverted Nipple, Retracted Nipple

In brief

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.

Key facts

Study ID: NCT05066100
Run by: Mayo Clinic
People needed: 0
Starts: 2022-12-01
Expected to finish: 2024-03-01
Last updated by the study team: 2022-12-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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