Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples (NCT05066100) | Clinical Trial Compass
WithdrawnNot Applicable
Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples
Stopped: This study was not started due to administrative considerations.
United States0Started 2022-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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