Engorgement Study With a Double Electric Breast Pump
Engorgement Study With the Simplisse Double Electric Breast Pump
1 other identifier
observational
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
June 14, 2012
CompletedJune 14, 2012
June 1, 2012
2 months
June 12, 2012
June 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Engorgement Relief
Relief of engorgement as measured by the engorgement scale.
10 minutes per subject
Study Arms (1)
Lactating women
Lactating women willing to use a breast pump.
Interventions
Use of breast pump for 10 minutes.
Eligibility Criteria
First 20 women arriving at the Newborn Care Center clinic in Reno, Nevada during their first week postpartum seeking lactation management assistance for engorgement.
You may qualify if:
- first week postpartum seeking lactation management assistance for engorgement, identified as clinically engorged by health care practitioner.
You may not qualify if:
- greater than one week postpartum
- less than 18 years of age
- non-English speakers
- not willing to use double electric breast pump
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Newborn Care Center Clinic
Reno, Nevada, 89502, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jimi Francis, MS,PhD,IBCLC
Foundation for Maternal Infant and Lactation Knowledge
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2012
First Posted
June 14, 2012
Study Start
March 1, 2011
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
June 14, 2012
Record last verified: 2012-06