Engorgement Study With a Double Electric Breast Pump

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Foundation for Maternal Infant and Lactation Knowledge
ClinicalTrials.gov Identifier:
NCT01619371
First received: June 12, 2012
Last updated: June 13, 2012
Last verified: June 2012

June 12, 2012
June 13, 2012
March 2011
May 2011   (final data collection date for primary outcome measure)
Engorgement Relief [ Time Frame: 10 minutes per subject ] [ Designated as safety issue: Yes ]
Relief of engorgement as measured by the engorgement scale.
Same as current
Complete list of historical versions of study NCT01619371 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Engorgement Study With a Double Electric Breast Pump
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Engorgement
Device: Simplisse Double Electric Breast Pump
Use of breast pump for 10 minutes.
Other Name: Simplisse Double Electric Breast Pump, 1005S
Lactating women
Lactating women willing to use a breast pump.
Intervention: Device: Simplisse Double Electric Breast Pump
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01619371
2614
Yes
Foundation for Maternal Infant and Lactation Knowledge
Foundation for Maternal Infant and Lactation Knowledge
Not Provided
Principal Investigator: Jimi Francis, MS,PhD,IBCLC Foundation for Maternal Infant and Lactation Knowledge
Foundation for Maternal Infant and Lactation Knowledge
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP