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Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples

NCT ID: NCT05066100

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2024-03-31

Brief Summary

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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

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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

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Inverted Nipple Retracted Nipple

Keywords

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Pregnancy Lactation Postpartum Flat Nipples Inverted Nipples Retracted Nipples

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pregnant women with FIRN

Women desiring to breastfeed and identified during their pregnancy as having flat, inverted or retracted nipples

Group Type EXPERIMENTAL

Prenatal Use of Supple Cups

Intervention Type OTHER

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.

Interventions

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Prenatal Use of Supple Cups

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Miriam (Miri) E. Levi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miriam E Levi, CNM, MBA

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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21-006665

Identifier Type: -

Identifier Source: org_study_id