NCT01857778

Brief Summary

There will be breast tissue changes after use of a breast pump.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
Last Updated

May 20, 2013

Status Verified

October 1, 2011

Enrollment Period

2 months

First QC Date

May 16, 2013

Last Update Submit

May 16, 2013

Conditions

To Collect Measurements of the NippleTo Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After BreastfeedingTo Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Expressing Milk With 3 Different Electric Breast Pumps.

Keywords

BreastfeedingBreast tissueBreast pump

Outcome Measures

Primary Outcomes (1)

  • Breast Tissue Change

    Lactating women used a 1 of 3 breast pumps or breastfed for 10 minutes.

    10 minutes

Study Arms (1)

Lactating Women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Lactating women.

You may qualify if:

  • Lactating women who were breastfeeding.

You may not qualify if:

  • Non breastfeeding or non lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renown Medical Center

Reno, Nevada, 89502, United States

Location

MeSH Terms

Conditions

Breast FeedingBreast Milk Expression

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Dr. Jimi Francis, PhD

    Foundation for M.I.L.K.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 16, 2013

First Posted

May 20, 2013

Study Start

August 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2012

Last Updated

May 20, 2013

Record last verified: 2011-10

Locations

US(1)