Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples

NCT05066100 | Withdrawn

• 1 other identifier: 21-006665
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inverted Nipple; Retracted Nipple

Keywords

Pregnancy; Lactation; Postpartum; Flat Nipples; Inverted Nipples; Retracted Nipples

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percent of women with established breastfeeding with adequate infant latch

  One week postpartum

Study Arms (1)

Pregnant women with FIRN

EXPERIMENTAL

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

Other: Prenatal Use of Supple Cups

Interventions

Prenatal Use of Supple Cups 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.

Pregnant women with FIRN

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Miriam E Levi, CNM, MBA

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 4, 2021
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

US (1)