Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples (FIRN)

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.

Study Overview

• Status: Withdrawn
• Conditions: Inverted Nipple; Retracted Nipple
• Intervention / Treatment: Other: Prenatal Use of Supple Cups

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester, Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregnant women with FIRN; Women desiring to breastfeed and identified during their pregnancy as having flat, inverted or retracted nipples	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At completion of 6 weeks of Supple Cups use during the prenatal period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One week postpartum

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Miriam E Levi, CNM, MBA, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Postpartum; Lactation; Flat Nipples; Inverted Nipples; Retracted Nipples
• Other Study ID Numbers: 21-006665

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No