Engorgement Study With a Double Electric Breast Pump

June 13, 2012 updated by: Foundation for Maternal Infant and Lactation Knowledge

Engorgement Study With the Simplisse Double Electric Breast Pump

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Reno, Nevada, United States, 89502
        • Newborn Care Center Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

First 20 women arriving at the Newborn Care Center clinic in Reno, Nevada during their first week postpartum seeking lactation management assistance for engorgement.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lactating women
Lactating women willing to use a breast pump.
Device: Simplisse Double Electric Breast Pump
Use of breast pump for 10 minutes.
Other Names:
  • Simplisse Double Electric Breast Pump, 1005S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engorgement Relief
Time Frame: 10 minutes per subject
Relief of engorgement as measured by the engorgement scale.
10 minutes per subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Maternal Infant and Lactation Knowledge

Investigators

  • Principal Investigator: Jimi Francis, MS,PhD,IBCLC, Foundation for Maternal Infant and Lactation Knowledge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (Estimate)

June 14, 2012

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2614

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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