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
  Purpose

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 Intervention
Engorgement
Device: Simplisse Double Electric Breast Pump

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Engorgement Study With the Simplisse Double Electric Breast Pump

Resource links provided by NLM:


Further study details as provided by Foundation for Maternal Infant and Lactation Knowledge:

Primary Outcome Measures:
  • Engorgement Relief [ Time Frame: 10 minutes per subject ] [ Designated as safety issue: Yes ]
    Relief of engorgement as measured by the engorgement scale.


Enrollment: 21
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Foundation for Maternal Infant and Lactation Knowledge
ClinicalTrials.gov Identifier: NCT01619371     History of Changes
Other Study ID Numbers: 2614
Study First Received: June 12, 2012
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hyperemia
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014