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Impact of Breast Shield Designs on Dynamics of Breast Pumping

NCT02719548 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-02-10

No results posted yet for this study

Summary

A prospective, randomized, 2-phase/crossover, single center premarket feasibility study. In phase I the comfort will be assessed, the occurence and types of adverse events will be recorded and the assessment how and if the different breast shield designs interact with the lacting breast during pumping. Phase II takes place at home; assessment of adverse events will be recorded and the assessment how the subjects perceives the comfort of the soft edge breast shield during mid term use at home.

Conditions

  • Lactation

Interventions

DEVICE

Soft edge oval - Hard oval - Modified PF breast shield

Treatment order: 1. soft-edge oval breast shield 2. Hard oval breast shield 3. modified PersonalFit breast shield

DEVICE

Modified PF breast shield - Soft edge oval - Hard oval

1. modified PersonalFit breast shield 2. soft-edge oval breast shield 3. Hard oval breast shield

DEVICE

Hard oval - Soft edge oval - Modified PF breast shield

1. Hard oval breast shield 2. soft-edge oval breast shield 3. modified PersonalFit breast shield

Sponsors & Collaborators

  • Medela AG

    lead INDUSTRY

Principal Investigators

  • Danielle Prime, PhD · Medela AG, Lättichstrasse 4b, 6340 Baar

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Switzerland

Study Locations

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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 NCT02719548 on ClinicalTrials.gov