Inverted NippleFIRNNCT05066100
Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples
A study testing Prenatal Use of Supple Cups in people with Inverted Nipple and Retracted Nipple, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Inverted Nipple, Retracted Nipple
- What is being tested?
- Prenatal Use of Supple Cups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2022to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
About this study
Official title: Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples to Improve Postpartum Breastfeeding Rates
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.
Read the 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.
- Conditions
- Inverted Nipple, Retracted Nipple
- Being tested
- Prenatal Use of Supple Cups
- Keywords
- Pregnancy, Lactation, Postpartum, Flat Nipples, Inverted Nipples, Retracted Nipples
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with FIRN | Experimental | Women desiring to breastfeed and identified during their pregnancy as having flat, inverted or retracted nipples Receives: Other: Prenatal Use of Supple Cups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At completion of 6 weeks of Supple Cups use during the prenatal period
Secondary outcomes (1)
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.
Measured: One week postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: This study was not started due to administrative considerations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inverted NippleStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam (Miri) E. Levi, Mayo Clinic
- Investigators
- Miriam E Levi, CNM, MBA, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066100
- Sponsor's protocol ID
- 21-006665
- Acronym
- FIRN
- Status last verified
- Dec 2022
- First submitted
- 6 Sep 2021
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples to Improve Postpartum Breastfeeding Rates
- ClinicalTrials.gov ID
- NCT05066100
- Acronym / sponsor ID
- FIRN / 21-006665
- Conditions
- Inverted Nipple, Retracted Nipple
- Keywords
- Pregnancy, Lactation, Postpartum, Flat Nipples, Inverted Nipples, Retracted Nipples
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was not started due to administrative considerations.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with FIRN | Experimental | Other: Prenatal Use of Supple CupsWomen desiring to breastfeed and identified during their pregnancy as having flat, inverted or retracted nipples |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal Use of Supple CupsFor 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. | Other | Pregnant women with FIRN |
Primary outcome
Percent of women with change in nipple elongation following use of Supple Cups in the prenatal period
Time frame: 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
1 secondary outcome
Percent of women with established breastfeeding with adequate infant latch
Time frame: One week postpartum
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam E Levi, CNM, MBA principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal Use of Supple Cups in people with Inverted Nipple and Retracted Nipple, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of women with change in nipple elongation following use of Supple Cups in the prenatal period (time frame: At completion of 6 weeks of Supple Cups use during the prenatal period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.