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Engorgement Study With a Double Electric Breast Pump

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ClinicalTrials.gov Identifier: NCT01619371
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):
Foundation for Maternal Infant and Lactation Knowledge

Brief Summary:
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.

Condition or disease Intervention/treatment
Engorgement Device: Simplisse Double Electric Breast Pump

Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Engorgement Study With the Simplisse Double Electric Breast Pump
Study Start Date : March 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

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 Name: Simplisse Double Electric Breast Pump, 1005S



Primary Outcome Measures :
  1. Engorgement Relief [ Time Frame: 10 minutes per subject ]
    Relief of engorgement as measured by the engorgement scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619371


Locations
United States, Nevada
Newborn Care Center Clinic
Reno, Nevada, United States, 89502
Sponsors and Collaborators
Foundation for Maternal Infant and Lactation Knowledge
Investigators
Principal Investigator: Jimi Francis, MS,PhD,IBCLC Foundation for Maternal Infant and Lactation Knowledge

Additional Information:
Responsible Party: Foundation for Maternal Infant and Lactation Knowledge
ClinicalTrials.gov Identifier: NCT01619371     History of Changes
Other Study ID Numbers: 2614
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Foundation for Maternal Infant and Lactation Knowledge:
breast pump
engorgement
lactation

Additional relevant MeSH terms:
Hyperemia
Vascular Diseases
Cardiovascular Diseases