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Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples

NCT05066100 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-12-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Miriam E Levi, CNM, MBA · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-12-31
Completion
2024-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05066100 on ClinicalTrials.gov