Engorgement Clinical Trial
Official title:
Engorgement Study With the Simplisse Double Electric Breast Pump
| Verified date | June 2012 |
| Source | Foundation for Maternal Infant and Lactation Knowledge |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | May 2011 |
| Est. primary completion date | May 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Newborn Care Center Clinic | Reno | Nevada |
| Lead Sponsor | Collaborator |
|---|---|
| Foundation for Maternal Infant and Lactation Knowledge |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Engorgement Relief | Relief of engorgement as measured by the engorgement scale. | 10 minutes per subject |