Engorgement Study With a Double Electric Breast Pump

NCT ID: NCT01619371

Last Updated: 2012-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to analyze the effectiveness of an FDA approved Class II medical device, the Simplisse Double Electric Breast Pump, in relieving the symptoms of engorgement.

Detailed Description

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Conditions

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Engorgement

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Lactating women

Lactating women willing to use a breast pump.

Simplisse Double Electric Breast Pump

Intervention Type DEVICE

Use of breast pump for 10 minutes.

Interventions

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Simplisse Double Electric Breast Pump

Use of breast pump for 10 minutes.

Intervention Type DEVICE

Other Intervention Names

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Simplisse Double Electric Breast Pump, 1005S

Eligibility Criteria

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Inclusion Criteria

* first week postpartum seeking lactation management assistance for engorgement, identified as clinically engorged by health care practitioner.

Exclusion Criteria

* greater than one week postpartum
* less than 18 years of age
* non-English speakers
* not willing to use double electric breast pump
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Foundation for Maternal Infant and Lactation Knowledge

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jimi Francis, MS,PhD,IBCLC

Role: PRINCIPAL_INVESTIGATOR

Foundation for Maternal Infant and Lactation Knowledge

Locations

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Newborn Care Center Clinic

Reno, Nevada, United States

Site Status

Countries

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United States

Related Links

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http://www.foundation4milk.org

home page of sponsoring foundation

Other Identifiers

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2614

Identifier Type: -

Identifier Source: org_study_id

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